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510(k) K791728

RSL'S ASSAY PROCEDURE QUANTITATION by Radioassay Systems Laboratories, Inc. — Product Code CGI

K791728 is an FDA 510(k) premarket notification submitted by Radioassay Systems Laboratories, Inc. for the device "RSL'S ASSAY PROCEDURE QUANTITATION". The FDA issued a decision of Substantially Equivalent on September 27, 1979. The device falls under product code CGI (Radioimmunoassay, Estriol), a Class I device regulated under 21 CFR 862.1265. Radioassay Systems Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1979
Date Received
August 30, 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 Radioassay Systems Laboratories, Inc.

  • K862204 — RSL (125I) ALDOSTERONE KIT (September 25, 1986)
  • K842960 — ANDROSTENEDIONE BY RIA (September 27, 1984)
  • K840886 — HYDROXYPROGESTERONE BY RIA 17A (April 18, 1984)
  • K831855 — HATCH KIT (July 28, 1983)
  • K802195 — DEHYDROEPIANDROSTERONE SULFATE KIT RIA (October 23, 1980)
  • K800126 — RSL (125 L) PROGESTERONE KIT (February 13, 1980)
  • K791999 — (125I) TESTOSTERONE KIT (October 30, 1979)
  • K791651 — TOTAL ESTROGENS KIT BY RIA (September 27, 1979)
  • K791835 — CORALENT COAT 125I CORTISOL RADIOIMM. (September 27, 1979)
  • K791740 — SERUM 11-DESOXYCORTISOL I AS TRACER (September 27, 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