510(k) Report

FDA applicant

Dade Intl., Inc.

Miami, FL31 decisions1988–19986 recalls

FDA records 31 decisions for Dade Intl., Inc. (Miami, FL) from 1988 to 1998: 30 510(k) clearances and 1 original PMA approval. Most are in product codes MMI (Immunoassay Method, Troponin Subunit) and JWY (Manual Antimicrobial Susceptibility Test Systems). Its devices cite 13 predicates, 1 of them its own earlier devices. 6 recalls are linked to its devices, 2 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Dade Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dade Intl., Inc. since 2007.

Recalls per year

2in 2018

2014: 2, 2 Class I2015: 12018: 2
2007high 2 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Dade Intl., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dade Intl., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MMIImmunoassay Method, Troponin Subunit2decisions
  • JWYManual Antimicrobial Susceptibility Test Systems2decisions
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)2decisions
  • JITCalibrator, Secondary2decisions
  • LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation1decision
  • DKBCalibrators, Drug Mixture1decision

Also: LEH (1), JIF (1), LDP (1), GKP (1), JOZ (1), CKA (1).

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K964139Sysmex CA-6000Dade Intl., Inc. · 19976cite it
  • K951890Stratus Cardiac Troponin-I Fluorometric Enzyme Immunmnoassay & Stratus Cardiac Troponin-I CalibratorsDade Intl., Inc. · 19952cite it
  • K963267Vancomycin Flex Reagent CartridgeDade Intl., Inc. · 19962cite it
  • K962817Drug Calibrator IIDade Intl., Inc. · 19961cites it
  • K963244Acetaminophen Flex Reagent CartridgeDade Intl., Inc. · 19961cites it
  • K970505Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa Collagen/Adp Test…Dade Intl., Inc. · 19971cites it

What has FDA decided for it lately?

  • K974343Dade InnovinDade Intl., Inc. · 1998
  • K970505Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa Collagen/Adp Test…Dade Intl., Inc. · 1997
  • K973974Dade Tru-Liquid Cardiac ControlDade Intl., Inc. · 1997
  • K973668Cardiac Troponin-I (Trop) CalibratorDade Intl., Inc. · 1997
  • K972524Dried Gram-Positive Mic/Combo PanelsDade Intl., Inc. · 1997
  • K972782Dade Stratus CK-MB Fluorometric Enzyme ImmunoassayDade Intl., Inc. · 1997
  • K972287Dade Tru-Liquid Bilirubin ControlDade Intl., Inc. · 1997
  • K964660Paramax Cholesterol ReagentDade Intl., Inc. · 1997

All 31 as Dade Intl., Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K062024Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme…Apr 19, 2018Class II
  • K062024Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot…Apr 19, 2018Class II
  • K970330QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension…Feb 24, 2015Class II
  • P870049Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number…Oct 17, 2014Class I
  • P870049Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are…Oct 17, 2014Class I
  • P870049MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed…Feb 7, 2005

Other applicant names beginning “Dade”

FDA records each applicant name separately; these may or may not be the same firm.

Dade Behring, Inc. 344Dade, Baxter Travenol Diagnostics, Inc. 44Dade Microscan, Inc. 40Dade Chemistry Systems, Inc. 13Dade Medical, Inc. 1