FDA applicant

Reagents Applications, Inc.

San Diego, CA63 decisions1980–19980 recalls

FDA records 63 decisions for Reagents Applications, Inc. (San Diego, CA) from 1980 to 1998: 63 510(k) clearances. Most are in product codes CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme…) and CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is 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 Reagents Applications, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Reagents Applications, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Reagents”

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

The Reagents of the University of Michigan 1

Reagents Applications, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Reagents”