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510(k) K903975

SEROZYME CORTISOL TEST KIT by Serono-Baker Diagnostics, Inc. — Product Code CGR

K903975 is an FDA 510(k) premarket notification submitted by Serono-Baker Diagnostics, Inc. for the device "SEROZYME CORTISOL TEST KIT". The FDA issued a decision of Substantially Equivalent on Jan 23, 1991. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Serono-Baker Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 23, 1991
Date Received
Aug 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cortisol
Device Class
Class II
Regulation Number
862.1205
Review Panel
CH
Submission Type

Other clearances by Serono-Baker Diagnostics, Inc.

  • K924257 — TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY (Nov 30, 1992)
  • K914886 — SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) (Mar 2, 1992)
  • K915164 — SRI TESTOSTERONE ENZYME IMMUNOASSAY (Mar 2, 1992)
  • K915602 — SRI DIGOXIN ENZYME IMMUNOASSAY (Jan 17, 1992)
  • K912937 — SR1 FREE T4 ENZYME IMMUNOASSAY (Nov 19, 1991)
  • K914462 — SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) (Oct 23, 1991)
  • K911912 — SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) (Sep 18, 1991)
  • K911217 — SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) (Aug 16, 1991)
  • K912318 — ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) (Jul 25, 1991)
  • K911396 — SR1 ESTRADIOL ENZYME IMMUNOASSAY (May 28, 1991)

Other clearances for product code CGR

  • K242190 — Access Cortisol; DxC 500i Clinical Analyzer (Mar 5, 2025)
  • K223038 — Access Cortisol (Feb 8, 2023)
  • K202136 — IDS Cortisol (Apr 13, 2021)
  • K203270 — IMMULITE/IMMULITE® 1000 Cortisol (Jan 15, 2021)
  • K202826 — IMMULITE® 2000 Cortisol (Jan 15, 2021)
  • K062626 — CORTISOL ELISA (Dec 20, 2006)
  • K060480 — VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METAB (Jul 3, 2006)
  • K052359 — IBL CORTISOL LIA TEST KIT (Oct 3, 2005)
  • K050202 — CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (Feb 9, 2005)
  • K042689 — NICHOLS ADVANTAGE CORTISOL (Dec 9, 2004)

FDA data resources