Home / 510(k) Clearances / K872879

510(k) K872879

DHEA-S RIA KIT by Endocrine Associates, Inc. — Product Code JKC

K872879 is an FDA 510(k) premarket notification submitted by Endocrine Associates, Inc. for the device "DHEA-S RIA KIT". The FDA issued a decision of Substantially Equivalent on October 23, 1987. The device falls under product code JKC (Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)), a Class I device regulated under 21 CFR 862.1245. Endocrine Associates, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1987
Date Received
July 21, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Device Class
Class I
Regulation Number
862.1245
Review Panel
CH
Submission Type

Other clearances by Endocrine Associates, Inc.

  • K872880 — CALCITONIN RIA KIT (August 13, 1987)

Other clearances for product code JKC

  • K040181 — ACCESS DHEA-S REAGENT ASSAY (March 24, 2004)
  • K003174 — ELECSYS DHEA-S (January 17, 2001)
  • K973897 — DHEA-S (November 13, 1997)
  • K962895 — DSL DHEA-S-7 (September 10, 1996)
  • K955114 — DSL AACTIVE DHEA EIA KIT (February 23, 1996)
  • K950524 — NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY (May 15, 1995)
  • K942051 — SR1 DHEA-S ENZYME IMMUNOASSAY (July 13, 1994)
  • K935014 — ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) (May 9, 1994)
  • K935806 — IMMULITE DHEA-S04 (April 26, 1994)
  • K935469 — SYNELISA DHEA-SULFATE (March 22, 1994)

FDA data resources