FDA applicant

Diagnostic Specialties

Metuchen, NJ8 decisions1981–19970 recalls

FDA records 8 decisions for Diagnostic Specialties (Metuchen, NJ) from 1981 to 1997: 8 510(k) clearances. Most are in product codes JIQ (Turbidimetric Method, Protein Or Albumin…) and JIR (Indicator Method, Protein Or Albumin (Urinary…). 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 Diagnostic Specialties’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diagnostic Specialties since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Diagnostic Specialties’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 “Diagnostic”

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

Diagnostic Products Corp. 324 Diagnostic Systems Laboratories, Inc. 94 Diagnostic Chemicals, Ltd. (Usa) 77 Diagnostic Reagents, Inc. 66 Diagnostic Chemicals, Ltd. 66 Diagnostic Hybrids, Inc. 37 Diagnostic Technology, Inc. 28 Diagnostic Solutions, Inc. 26 Diagnostic Ultrasound Corp. 16 Diagnostic Systems 14 Diagnostic Reagent Tech. 10 Diagnostic Monitoring Software 5

Diagnostic Specialties

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Diagnostic”