JKC · Class I · 21 CFR 862.1245

FDA Product Code JKC: Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)

Leading manufacturers include Diagnostic Systems Laboratories, Inc., Diagnostic Products Corp. and Roche Diagnostics Corp..

28
Total
28
Cleared
61d
Avg days
1979
Since

FDA 510(k) Cleared Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) Devices (Product Code JKC)

28 devices
1–24 of 28
Cleared Mar 24, 2004
ACCESS DHEA-S REAGENT ASSAY
K040181
Beckman Coulter, Inc.
Chemistry · 57d
Cleared Jan 17, 2001
ELECSYS DHEA-S
K003174
Roche Diagnostics Corp.
Chemistry · 99d
Cleared Sep 10, 1996
DSL DHEA-S-7
K962895
Diagnostic Systems Laboratories, Inc.
Chemistry · 47d
Cleared Feb 23, 1996
DSL AACTIVE DHEA EIA KIT
K955114
Diagnostic Systems Laboratories, Inc.
Chemistry · 106d
Cleared May 09, 1994
ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)
K935014
Diagnostic Systems Laboratories, Inc.
Chemistry · 201d
Cleared Apr 26, 1994
IMMULITE DHEA-S04
K935806
Diagnostic Products Corp.
Chemistry · 145d
Cleared Sep 10, 1990
DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000)
K903616
Diagnostic Systems Laboratories, Inc.
Chemistry · 33d
Cleared Apr 26, 1989
DSL 7900 ACTIVE DHEA-S (DSL #7900)
K891478
Diagnostic Systems Laboratories, Inc.
Chemistry · 41d
Cleared Aug 02, 1985
SOPHEIA DHEA-SO4 EIA KIT
K852847
Diagnostic Products Corp.
Chemistry · 28d
Cleared Apr 25, 1985
ACTIVE DHEA-SULFATE DSL3500
K851239
Diagnostic Systems Laboratories, Inc.
Chemistry · 29d
Cleared Aug 17, 1984
COAT-A-COUNT DHEA-SO4 RIA KIT
K842552
Diagnostic Products Corp.
Chemistry · 46d
Cleared Aug 17, 1984
COAT-A-COUNT DHEA RIA KIT
K842606
Diagnostic Products Corp.
Chemistry · 43d
Cleared Aug 16, 1983
DHEA-SULFATE I RIA KIT
K832154
Diagnostic Systems Laboratories, Inc.
Chemistry · 42d

About Product Code JKC - Regulatory Context