JJI · Class I · 21 CFR 862.2500

FDA Product Code JJI: Analyzer, Enzyme, For Clinical Use

Leading manufacturers include Bio-Rad, Abbott Laboratories and Bd Becton Dickinson Vacutainer Systems Preanalytic.

8
Total
8
Cleared
58d
Avg days
1977
Since

FDA 510(k) Cleared Analyzer, Enzyme, For Clinical Use Devices (Product Code JJI)

8 devices
1–8 of 8
Cleared Jul 30, 1997
CODA AUTOMATED EIA ANALYZER
K972024
Bio-Rad
Chemistry · 58d
Cleared Dec 19, 1994
ABBOTT IMX 2 ANALYZER
K944731
Abbott Laboratories
Toxicology · 98d
Cleared Jun 16, 1993
ABBOTT IMX2 ANALYER
K931970
Abbott Laboratories
Chemistry · 55d
Cleared Apr 21, 1993
RADIAS AUTOMATED IMMUNOASSAY SYSTEM
K930898
Bio-Rad
Chemistry · 58d
Cleared Aug 14, 1978
QUICKRATE REACTION RATE ANALYZER
K780972
Olympus Corp.
Chemistry · 63d
Cleared Apr 26, 1977
LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE
K770401
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 55d

About Product Code JJI - Regulatory Context