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510(k) K903359

MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT by Immunotech Corp. — Product Code CGI

K903359 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT". The FDA issued a decision of Substantially Equivalent on August 22, 1990. The device falls under product code CGI (Radioimmunoassay, Estriol), a Class I device regulated under 21 CFR 862.1265. Immunotech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1990
Date Received
July 25, 1990
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

Other clearances by Immunotech Corp.

  • K954188 — OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL (November 3, 1995)
  • K946335 — OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES (October 20, 1995)
  • K953498 — OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL (September 8, 1995)
  • K952789 — OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES (August 14, 1995)
  • K952182 — OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES (July 5, 1995)
  • K950626 — OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES (May 5, 1995)
  • K934012 — FT4 RADIOIMMUNOASSAY (November 16, 1993)
  • K931228 — PROGESTERONE RADIOIMMUNOASSAY KIT (October 22, 1993)
  • K911634 — MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST (June 24, 1991)
  • K911153 — MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT (June 18, 1991)

Other clearances for product code CGI

  • K974721 — UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SY (March 3, 1998)
  • K962875 — ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA (August 23, 1996)
  • 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)
  • 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)

FDA data resources