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510(k) K791651

TOTAL ESTROGENS KIT BY RIA by Radioassay Systems Laboratories, Inc. — Product Code JMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1979
Date Received
August 21, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Estrogens, Nonpregnancy
Device Class
Class I
Regulation Number
862.1275
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)
  • K791740 — SERUM 11-DESOXYCORTISOL I AS TRACER (September 27, 1979)
  • K791728 — RSL'S ASSAY PROCEDURE QUANTITATION (September 27, 1979)
  • K791652 — ESTRADIOL KIT BY RIA (September 27, 1979)

Other clearances for product code JMD

  • K781009 — ANALYZER, SERUM IRON & TOTAL IRON BINDIN (July 27, 1978)