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

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

21 CFR 862.1245 / Clinical Chemistry
FDA source (opens on fda.gov)

JKC is the FDA product code for Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate), a class I device type, regulated under 21 CFR 862.1245. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
JKC
Device name
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Regulation
21 CFR 862.1245
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
28
Ingested recalls
7

Clearances, product code JKC

By decision year
28 clearances under product code JKC with a decision year between 1979 and 2004, 1984 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JKC by decision year
YearClearances
19791
19801
19811
19823
19831
19844
19853
19871
19891
19901
19931
19944
19951
19962
19971
20011
20041

Applicants with the most clearances

Product code JKC
Applicants holding the most 510(k) clearances under product code JKC
ApplicantClearances
Diagnostic Systems Laboratories, Inc.7
Siemens Healthcare Diagnostics Inc.5
Nichols Institute2
Wien Laboratories, Inc.2
Biotecx Laboratories, Inc.1
Cambridge Medical Technology1
Elias U.S.A., Inc.1
Endocrine Associates, Inc.1
Immuchem Corp.1
Immunalysis Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order