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510(k) K962875

ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA by Diagnostic Systems Laboratories, Inc. — Product Code CGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1996
Date Received
July 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Estriol
Device Class
Class I
Regulation Number
862.1265
Review Panel
CH
Submission Type

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Other clearances for product code CGI

  • K974721 — UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SY (March 3, 1998)
  • K955356 — ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL (May 15, 1996)
  • K932989 — COAT-A-COUNT FREE ESTRIOL (December 19, 1994)
  • K944490 — AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT (December 9, 1994)
  • K920576 — AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL (March 23, 1992)
  • K903359 — MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT (August 22, 1990)
  • K860900 — IMMPULSE FREE ESTRIOL ASSAY REAGENTS (April 28, 1986)
  • K850787 — SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY (March 26, 1985)
  • K844767 — RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO (February 1, 1985)
  • K844511 — TDX TOTAL ESTRIOL (January 18, 1985)