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510(k) K970386

ACS ESTADIOL-6 II by Chiron Diagnostics Corp. — Product Code CHP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1997
Date Received
February 3, 1997
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 Chiron Diagnostics Corp.

  • K992157 — CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY (August 5, 1999)
  • K991582 — CHIRON DIAGNOSTICS ACS: 180 FOLATE (June 30, 1999)
  • K991692 — CHIRON DIAGNOSTICS ACS: 180 FT3 (June 18, 1999)
  • K982680 — CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY (October 15, 1998)
  • K981839 — ACS:CENTAUR PSA2 IMMUNOASSAY (August 12, 1998)
  • K981478 — ACS:CENTAUR CEA (August 12, 1998)
  • K981592 — ACS:CENTAUR AFP (July 7, 1998)
  • K980528 — CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) (March 3, 1998)
  • K974029 — ACS TOBRAMYCIN (February 12, 1998)
  • K974325 — CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN (December 8, 1997)

Other clearances for product code CHP

  • K041349 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM (September 24, 2004)
  • K973901 — 17 B-ESTRADIOL (ELISA) (November 24, 1997)
  • K973743 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (October 31, 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)
  • K951360 — ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (May 2, 1995)