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510(k) K841947

ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT by Sorin Biomedica, Fiat, USA, Inc. — Product Code CHP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1984
Date Received
May 14, 1984
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

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Other clearances for product code CHP

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  • K973743 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (October 31, 1997)
  • K970386 — ACS ESTADIOL-6 II (June 4, 1997)
  • K970643 — VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CA (March 18, 1997)
  • K970126 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) (February 25, 1997)
  • K965109 — ELECSYS ESTRADIOL ASSAY (February 18, 1997)
  • K955647 — VIDAS ESTRADIOL II (E2II) ASSAY (February 6, 1996)
  • K954697 — CIBA CORNING ACS ESTRADIOL-6 ASSAY (December 13, 1995)
  • K953605 — ULTRA-SENSITIVE ESTRADIOL (October 2, 1995)