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FDA Product Code

FDA Product Code JJI — Clearance Directory

Device Class
Class I
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.2500

510(k) Clearances — 8 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K972024 CODA AUTOMATED EIA ANALYZER Bio-Rad 1997-07-30 Traditional PDF ↗
K944731 ABBOTT IMX 2 ANALYZER Abbott Laboratories 1994-12-19 Traditional PDF ↗
K931970 ABBOTT IMX2 ANALYER Abbott Laboratories 1993-06-16 Traditional PDF ↗
K930898 RADIAS AUTOMATED IMMUNOASSAY SYSTEM Bio-Rad 1993-04-21 Traditional PDF ↗
K790073 ANALYZER, IMPACT 100 Gilford Instrument Laboratories, Inc. 1979-02-22 Traditional PDF ↗
K780972 QUICKRATE REACTION RATE ANALYZER Olympus Corp. 1978-08-14 Traditional PDF ↗
K771591 MINISTAT-S CHEMISTRY ANALYZER Biokinetix Corp. 1977-09-20 Traditional PDF ↗
K770401 LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE Bd Becton Dickinson Vacutainer Systems Preanalytic 1977-04-26 Traditional PDF ↗

Product code JJI · Class I · Clinical Chemistry. Data: openFDA.