# Sterling Diagnostics, Inc.

- Location (FDA's records): Sterling Heights, MI
- FDA decisions: 41 (1985–1993): 41 510(k) clearances
- Product codes: CEK (2), CDT (2), JGJ (1), CJE (1), CFH (1), CEO (1), CKE (1), LFQ (1), CIQ (1), CKA (1), CHH (1), JKF (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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K921412: Microprotein Reagent Set (Jan 21, 1993)
- K914609: Triglycerides Reagent Set (Nov 7, 1991)
- K914039: Sodium Reagent Set (Oct 31, 1991)
- K914040: Phospholipid Reagent Set (Oct 30, 1991)
- K862255: Lactate Dehydrogenase (LDH) Reagent Set (UV Rate) (Jul 29, 1986)
- K861962: Vanilmandelic Acid (Vma) Reagent Set (Jul 7, 1986)
- K862256: Alkaline Phosphatase (PNPP Rate) Reagent Set (Jul 1, 1986)
- K862210: Urea Nitrogen (GLDH) Reagent Set (UV) (Jul 1, 1986)

Source page: https://510kreport.com/company/sterling-diagnostics