# Diagnostic Specialties

- Location (FDA's records): Metuchen, NJ
- FDA decisions: 8 (1981–1997): 8 510(k) clearances
- Product codes: JIQ (1), JIR (1), JHJ (1), CEJ (1), LCX (1), LCP (1), GIS (1), CGA (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K971458: Enzip Immunoturbidimetric Microalbumin Assay Kit (Sep 2, 1997)
- K941001: Enzip Immunoturbidmetric Fibrinogen Assay Kit (Aug 30, 1994)
- K930823: Protein-Bound Glucose Assayn Kit (Aug 19, 1993)
- K922032: Enzip Urinary Microalbumin Test (Jul 30, 1992)
- K831180: Pregna-Cert, Slide Pregnancy Test (May 27, 1983)
- K823109: Generic Pregnancy Test (Nov 10, 1982)
- K813608: Potassium Reagent Set (Jan 22, 1982)
- K813412: Glucose Enzyme-Color Reagent Set (Dec 31, 1981)

Source page: https://510kreport.com/company/diagnostic-specialties