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510(k) K896145

ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY by Serono-Baker Diagnostics, Inc. — Product Code CHP

K896145 is an FDA 510(k) premarket notification submitted by Serono-Baker Diagnostics, Inc. for the device "ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY". The FDA issued a decision of Substantially Equivalent on Dec 27, 1989. The device falls under product code CHP (Radioimmunoassay, Estradiol), a Class I device regulated under 21 CFR 862.1260. Serono-Baker Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 27, 1989
Date Received
Oct 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Estradiol
Device Class
Class I
Regulation Number
862.1260
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 CHP

  • K041349 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM (Sep 24, 2004)
  • K973901 — 17 B-ESTRADIOL (ELISA) (Nov 24, 1997)
  • K973743 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (Oct 31, 1997)
  • K970386 — ACS ESTADIOL-6 II (Jun 4, 1997)
  • K970643 — VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CA (Mar 18, 1997)
  • K970126 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) (Feb 25, 1997)
  • K965109 — ELECSYS ESTRADIOL ASSAY (Feb 18, 1997)
  • K955647 — VIDAS ESTRADIOL II (E2II) ASSAY (Feb 6, 1996)
  • K954697 — CIBA CORNING ACS ESTRADIOL-6 ASSAY (Dec 13, 1995)
  • K953605 — ULTRA-SENSITIVE ESTRADIOL (Oct 2, 1995)

FDA data resources