# Gamma Biologicals, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 21 (1976–1986): 21 510(k) clearances
- Product codes: KSX (2), KHE (2), KTN (2), KSI (2), GTZ (1), GSZ (1), DCK (1), KSG (1), JHJ (1), DHR (1), DEM (1), GTQ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 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
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)

## Its most-cited devices
- K861016: Gamma Slide Test for Infectious Mononucleosis (1986), cited by 1

## Recent decisions
- K864207: Disposable Test Cards/Gamma Slide Test Infect Mono (Dec 3, 1986)
- K861016: Gamma Slide Test for Infectious Mononucleosis (Apr 18, 1986)
- K832473: Gamma Slide Test for Pregnancy (Aug 16, 1983)
- K820647: Gamma Fetal Bleed Screening Test (May 12, 1982)
- K820072: FE-Cult Plus (Mar 4, 1982)
- K813342: Gamma Chloroquine Diphosphate Solution (Mar 4, 1982)
- K811752: FE-Cult Plus (Nov 2, 1981)
- K802533: Gamma Lewis Blood Group Substance (Nov 12, 1980)

Source page: https://510kreport.com/company/gamma-biologicals