510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JJIClass I

Analyzer, Enzyme, For Clinical Use

21 CFR 862.2500 / Clinical Chemistry
FDA source (opens on fda.gov)

JJI is the FDA product code for Analyzer, Enzyme, For Clinical Use, a class I device type, regulated under 21 CFR 862.2500. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JJI
Device name
Analyzer, Enzyme, For Clinical Use
Regulation
21 CFR 862.2500
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
1

Clearances, product code JJI

By decision year
8 clearances under product code JJI with a decision year between 1977 and 1997, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JJI by decision year
YearClearances
19772
19781
19791
19932
19941
19971

Applicants with the most clearances

Product code JJI
Applicants holding the most 510(k) clearances under product code JJI
ApplicantClearances
Abbott Medical2
Bio-Rad2
BD Becton Dickinson Vacutainer Systems Preanalytic1
Biokinetix Corp.1
Gilford Instrument Laboratories, Inc.1
Olympus Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code