510(k) Report

FDA applicant

Verichem Laboratories, Inc.

Providence, RI14 decisions1988–20128 recalls

FDA records 14 decisions for Verichem Laboratories, Inc. (Providence, RI) from 1988 to 2012: 14 510(k) clearances. Most are in product codes JIX (Calibrator, Multi-Analyte Mixture) and JIS (Calibrator, Primary). Its devices cite 3 predicates, 1 of them its own earlier devices. 8 recalls are linked to its devices.

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 Verichem Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JIXCalibrator, Multi-Analyte Mixture6decisions
  • JISCalibrator, Primary2decisions
  • DKBCalibrators, Drug Mixture2decisions
  • DNNCalibrators, Ethyl Alcohol1decision
  • JJRElectrolyte Controls (Assayed And Unassayed)1decision
  • JITCalibrator, Secondary1decision

Also: JJT (1).

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K875285Multi-Chemistry Linearity StandardVerichem Laboratories, Inc. · 19882cite it

What has FDA decided for it lately?

  • K112834Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit, Urine Uric Acid Standard…Verichem Laboratories, Inc. · 2012
  • K974290Microprotein Standard KitVerichem Laboratories, Inc. · 1997
  • K973345Matrix Plus Multi-Calibrator KitVerichem Laboratories, Inc. · 1997
  • K972333Ammonia/Iron Standard KitVerichem Laboratories, Inc. · 19975 recalls
  • K924904HDL-Cholesterol Standard, ModificationVerichem Laboratories, Inc. · 1993
  • K912513Electrolyte ControlVerichem Laboratories, Inc. · 1991
  • K901113Matrix Plus (TM) Chemistry Reference StandardVerichem Laboratories, Inc. · 1990
  • K882059Bilirubin StandardVerichem Laboratories, Inc. · 1988

All 14 as Verichem Laboratories, Inc. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K882117Mega Diagnostics Alcohol Standard (Cat.# A7504-STD) packaged in 5ml vials.Sep 20, 2006
  • K972333Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vialsSep 20, 2006
  • K882117Alcohol Standard, 100 mg/dl, Pointe Scientific Inc., Canton, MI; Catalog # A7504-STD.Jun 9, 2006
  • K972333Alcohol Control, Level 1 sold by Pointe Scientific; Catalog # 7-A7504-CTL-L1.Jun 9, 2006
  • K972333Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in…Jun 9, 2006
  • K972333Alcohol Control sold by Pointe Scientific; Catalog # 7-A7504-CTL.Jun 9, 2006