# Dade Intl., Inc.

- Location (FDA's records): Miami, FL
- FDA decisions: 31 (1988–1998): 30 510(k) clearances and 1 original PMA approval
- Product codes: MMI (2), JWY (2), JJX (2), JIT (2), LON (1), DKB (1), LEH (1), JIF (1), LDP (1), GKP (1), JOZ (1), CKA (1)
- Predicates its devices cite: 13 (1 its own); citations of its devices by later devices: 19 (1 its own)
- Recalls linked to its devices: 6 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Chrono-Log Corp.: 3 (https://510kreport.com/company/chrono-log)
- E.I. Dupont DE Nemours & Co., Inc.: 2 (https://510kreport.com/company/ei-dupont-de-nemours)
- Baxter Healthcare Corp: 2 (https://510kreport.com/company/baxter-healthcare)
- Medical Laboratory Automation Systems, Inc.: 1 (https://510kreport.com/company/medical-laboratory-automation-systems)
- Baxter Diagnostics, Inc.: 1 (https://510kreport.com/company/baxter-diagnostics)
- Medical Analysis Systems, Inc.: 1 (https://510kreport.com/company/medical-analysis-systems)
- American Dade: 1 (https://510kreport.com/company/american-dade)
- Bio-Rad: 1 (https://510kreport.com/company/bio-rad)

## Firms that cite its devices most
- Dade Behring, Inc.: 15 (https://510kreport.com/company/dade-behring)
- Careside, Inc.: 1 (https://510kreport.com/company/careside)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Diagnostic Products Corp.: 1 (https://510kreport.com/company/diagnostic-products)

## Its most-cited devices
- K964139: Sysmex CA-6000 (1997), cited by 6
- K951890: Stratus Cardiac Troponin-I Fluorometric Enzyme Immunmnoassay & Stratus Cardiac Troponin-I Calibrators (1995), cited by 2
- K963267: Vancomycin Flex Reagent Cartridge (1996), cited by 2
- K962817: Drug Calibrator II (1996), cited by 1
- K963244: Acetaminophen Flex Reagent Cartridge (1996), cited by 1
- K970505: Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa Collagen/Adp Test Cartridge/ (1997), cited by 1

## Recent decisions
- K974343: Dade Innovin (Jul 22, 1998)
- K970505: Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa Collagen/Adp Test Cartridge/ (Nov 17, 1997)
- K973974: Dade Tru-Liquid Cardiac Control (Nov 6, 1997)
- K973668: Cardiac Troponin-I (Trop) Calibrator (Oct 20, 1997)
- K972524: Dried Gram-Positive Mic/Combo Panels (Sep 8, 1997)
- K972782: Dade Stratus CK-MB Fluorometric Enzyme Immunoassay (Aug 15, 1997)
- K972287: Dade Tru-Liquid Bilirubin Control (Jul 7, 1997)
- K964660: Paramax Cholesterol Reagent (Jun 4, 1997)

Source page: https://510kreport.com/company/dade-intl