# American Dade

- Location (FDA's records): Mchenry, IL
- FDA decisions: 149 (1980–1987): 149 510(k) clearances
- Product codes: JJY (9), GGP (9), JPK (5), GIO (5), JIX (4), JIT (4), JJS (3), KHQ (3), GJS (3), CIG (3), JQW (3), LAN (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Metrika, Inc.: 2 (https://510kreport.com/company/metrika)
- Dade Behring, Inc.: 1 (https://510kreport.com/company/dade-behring)
- Dade Intl., Inc.: 1 (https://510kreport.com/company/dade-intl)
- R2 Diagnostics, Inc.: 1 (https://510kreport.com/company/r2-diagnostics)

## Its most-cited devices
- K850570: Stratus HCG Fluorometric Enzyme Immunoassay (1985), cited by 1
- K863594: Actin FSL Activated PTT Reagent (1986), cited by 1
- K871977: Dade Moni-Trol Chemistry Control/Calibrator (1987), cited by 1
- K860906: Stratus Immunoassay Controls, Levels I, II, Iii (1986), cited by 1
- K812424: CI-Trol Heparin Controls, Low/High (1981), cited by 1

## Recent decisions
- K873051: Stratus (R) HFSH Fluorometric Enzyme Immunoassay (Oct 20, 1987)
- K873171: Stratus (R) CK-MB Fluorometric Enzyme Immunoassay (Sep 29, 1987)
- K873052: Stratus (R) HLH Fluorometric Enzyme Immunoassay (Sep 14, 1987)
- K872789: Paramax Urine/CSF Calibrator (Sep 2, 1987)
- K872195: Data-FI Dimertest Latex Assay (Aug 6, 1987)
- K872196: Aqueous Blood Gas/Electrolyte Contr Lev I,II & Iii (Jul 31, 1987)
- K871972: Stratus Ige Fluorometric Enzyme Immunoassay (Jul 21, 1987)
- K871977: Dade Moni-Trol Chemistry Control/Calibrator (Jul 9, 1987)

Source page: https://510kreport.com/company/american-dade