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510(k) K801424

ESTRIOL RIA KIT FOR USE WITH GAMMAFLO by Squibb & Sons, Inc. — Product Code CGI

K801424 is an FDA 510(k) premarket notification submitted by Squibb & Sons, Inc. for the device "ESTRIOL RIA KIT FOR USE WITH GAMMAFLO". The FDA issued a decision of Substantially Equivalent on July 21, 1980. The device falls under product code CGI (Radioimmunoassay, Estriol), a Class I device regulated under 21 CFR 862.1265. Squibb & Sons, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1980
Date Received
June 17, 1980
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 Squibb & Sons, Inc.

  • K821174 — TSH-SQUIBB RADIOIMMUNOASSAY KIT (May 14, 1982)
  • K800750 — STOMAHESIVE STERILE WAFER (May 8, 1980)
  • K770726 — RIA KIT, T4 CLASP (April 28, 1977)
  • K761267 — ANGIOTENSIN I IMMUTOPE KIT (December 30, 1976)

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)
  • 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)

FDA data resources