# Smithkline Diagnostics, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 42 (1976–1996): 42 510(k) clearances
- Product codes: IYO (5), JHS (4), KHE (4), CFJ (3), CIT (2), CHH (2), CKA (2), LYR (2), CFR (2), CDT (2), CKB (1), DND (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 5 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Alfa Scientific Designs, Inc.: 2 (https://510kreport.com/company/alfa-scientific-designs)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)

## Its most-cited devices
- K880499: Hemoccult Sensitive Test (1988), cited by 2
- K934863: Flexsure HP (1994), cited by 2
- K821674: Spinchem Acid Phosphatase Reagent (1982), cited by 1

## Recent decisions
- K961062: Flexsure Obt (Nov 6, 1996)
- K960183: Flexsure HP,Controls for Flexsurehp,Flexpack HP (Abbott Diagnostics)Andcontrols for Flexpack HP (Abbott Diagnostics) (Jun 7, 1996)
- K934863: Flexsure HP (May 18, 1994)
- K880499: Hemoccult Sensitive Test (May 23, 1988)
- K875131: (SKD) Cholesterol Test Kit (Mar 1, 1988)
- K862849: Hemoccult Wipe Test (Dec 9, 1986)
- K854723: SKD Electrochemical System (Ecs) (Mar 5, 1986)
- K852841: Rapid Direct Strep a Latex Agglutination Test (Jul 24, 1985)

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