FDA applicant

Baxter Diagnostics, Inc.

Miami, FL72 decisions1988–19950 recalls

FDA records 72 decisions for Baxter Diagnostics, Inc. (Miami, FL) from 1988 to 1995: 72 510(k) clearances. Most are in product codes JWY (Manual Antimicrobial Susceptibility Test Systems) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Baxter Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Baxter”

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

Baxter Healthcare Corp 574 Baxter Edwards 11 Baxter Bentley Laboratories, Inc. 3 Baxter Healthcare Corportation 3 Baxter Healthcare Corporation - Renal Division 2 Baxter/ Synovis Micro Companies Alliance, Inc. 2 Baxter Healthcare Corp/ Excel Medical 1 Baxter Centre For Medical Research 1 Baxter Healthcare Corproration 1 Baxter Corp. 1 Baxter Interwoven Offsite 1 Baxter Healthcare Corp., Bioscience 1

Baxter Diagnostics, 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 “Baxter”