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

Fluorometric Measurement, Porphyrins

21 CFR 862.1595 / Clinical Chemistry
FDA source (opens on fda.gov)

JKJ is the FDA product code for Fluorometric Measurement, Porphyrins, a class I device type, regulated under 21 CFR 862.1595. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JKJ
Device name
Fluorometric Measurement, Porphyrins
Regulation
21 CFR 862.1595
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
3
Ingested recalls
0

Clearances, product code JKJ

By decision year
3 clearances under product code JKJ with a decision year between 1978 and 1989, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JKJ by decision year
YearClearances
19781
19871
19891

Applicants with the most clearances

Product code JKJ
Applicants holding the most 510(k) clearances under product code JKJ
ApplicantClearances
Helena Laboratories, Corp.2
Whale Scientific, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code