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510(k) K772323

RIANEN ESTRIOL RIA KIT by New England Nuclear — Product Code CGI

K772323 is an FDA 510(k) premarket notification submitted by New England Nuclear for the device "RIANEN ESTRIOL RIA KIT". The FDA issued a decision of Substantially Equivalent on January 5, 1978. The device falls under product code CGI (Radioimmunoassay, Estriol), a Class I device regulated under 21 CFR 862.1265. New England Nuclear has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1978
Date Received
December 19, 1977
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 New England Nuclear

  • K841478 — RIANEN CYCLIC-AMP RADIOIMMUNOASSAY (June 14, 1984)
  • K840301 — RIANEN ESTRIOL RADIOIMMUNOASSAY KIT (March 30, 1984)
  • K834038 — RIANEN FOLLICLE STIMULATING HORMONE (January 30, 1984)
  • K833376 — RIANEN LUTEINIZING HORMONE RIA KIT (December 20, 1983)
  • K831345 — RIANEN PROLACTIN 125I KIT (June 8, 1983)
  • K801245 — ATOMLIGHT (LIQUID SCINTILLATION SOLUTION (June 20, 1980)
  • K792175 — RIANEN, VITAMIN B12 ASSAY SYSTEM (November 13, 1979)
  • K790817 — RIA KIT, QUANTITATION OF PROSTATIC ACID (May 7, 1979)
  • K782110 — RIA KIT, RIANEN CORTISOL (January 26, 1979)
  • K781888 — ASSAY SYSTEM, FERRITIN I KIT (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