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510(k) K931601

CHEMILUMINESCENCE DHEA-S IMMUNOASSAY by Nichols Institute — Product Code JKC

K931601 is an FDA 510(k) premarket notification submitted by Nichols Institute for the device "CHEMILUMINESCENCE DHEA-S IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on July 27, 1993. The device falls under product code JKC (Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)), a Class I device regulated under 21 CFR 862.1245. Nichols Institute has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1993
Date Received
April 1, 1993
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 Nichols Institute

  • K952559 — ERYTHROPOIETIN IMMUNOASSAY KIT (May 29, 1996)
  • K952505 — INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) (July 3, 1995)
  • K946247 — IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 (June 23, 1995)
  • K950524 — NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY (May 15, 1995)
  • K932650 — ERYTHROPOIETIN IMMUNOASSAY KIT (March 11, 1994)
  • K931600 — CHEMILUMINESCENCE FREE T3 IMMUNOASSAY (September 8, 1993)
  • K931777 — APO A-1 CHEMILUMINESCENCE ASSAY (August 16, 1993)
  • K926396 — ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT (July 27, 1993)
  • K931311 — THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT (May 14, 1993)
  • K930777 — THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT (April 8, 1993)

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