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510(k) K802195

DEHYDROEPIANDROSTERONE SULFATE KIT RIA by Radioassay Systems Laboratories, Inc. — Product Code JKC

K802195 is an FDA 510(k) premarket notification submitted by Radioassay Systems Laboratories, Inc. for the device "DEHYDROEPIANDROSTERONE SULFATE KIT RIA". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code JKC (Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)), a Class I device regulated under 21 CFR 862.1245. Radioassay Systems Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1980
Date Received
September 10, 1980
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 Radioassay Systems Laboratories, Inc.

  • K862204 — RSL (125I) ALDOSTERONE KIT (September 25, 1986)
  • K842960 — ANDROSTENEDIONE BY RIA (September 27, 1984)
  • K840886 — HYDROXYPROGESTERONE BY RIA 17A (April 18, 1984)
  • K831855 — HATCH KIT (July 28, 1983)
  • K800126 — RSL (125 L) PROGESTERONE KIT (February 13, 1980)
  • K791999 — (125I) TESTOSTERONE KIT (October 30, 1979)
  • K791651 — TOTAL ESTROGENS KIT BY RIA (September 27, 1979)
  • K791835 — CORALENT COAT 125I CORTISOL RADIOIMM. (September 27, 1979)
  • K791740 — SERUM 11-DESOXYCORTISOL I AS TRACER (September 27, 1979)
  • K791728 — RSL'S ASSAY PROCEDURE QUANTITATION (September 27, 1979)

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