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

Radioimmunoassay, Compound S (11-Deoxycortisol)

21 CFR 862.1185 / Clinical Chemistry
FDA source (opens on fda.gov)

JKB is the FDA product code for Radioimmunoassay, Compound S (11-Deoxycortisol), a class I device type, regulated under 21 CFR 862.1185. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
JKB
Device name
Radioimmunoassay, Compound S (11-Deoxycortisol)
Regulation
21 CFR 862.1185
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
1
Ingested recalls
0

Clearances, product code JKB

By decision year
1 clearance under product code JKB with a decision year between 1979 and 1979, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JKB by decision year
YearClearances
19791

Applicants with the most clearances

Product code JKB
Applicants holding the most 510(k) clearances under product code JKB
ApplicantClearances
Radioassay Systems Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code