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510(k) K792189

NORDICLAB TOTAL ESTRIOL RIA TEST by Nordiclab Intl. — Product Code CGI

K792189 is an FDA 510(k) premarket notification submitted by Nordiclab Intl. for the device "NORDICLAB TOTAL ESTRIOL RIA TEST". The FDA issued a decision of Substantially Equivalent on November 13, 1979. The device falls under product code CGI (Radioimmunoassay, Estriol), a Class I device regulated under 21 CFR 862.1265. Nordiclab Intl. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1979
Date Received
October 31, 1979
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 Nordiclab Intl.

  • K801988 — NORDICLAB PROSTATIC ACID PHOSPHATASE RIA (September 26, 1980)
  • K801989 — NORDICLAB FERRITIN IRMA TEST (September 16, 1980)
  • K800920 — NORDICLAB ESTRADIOL RIA TEST (May 14, 1980)
  • K800921 — NORDICLAB TESTOSTERONE RIA TEST (May 14, 1980)
  • K800922 — NORDICLAB PROGESTERONE RIA TEST (May 14, 1980)
  • K782157 — IRMA TEST, NORDICLAB FERRITIN (January 17, 1979)
  • K782099 — RIA TEST, NORDICALB HPL (January 10, 1979)

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