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510(k) K800126

RSL (125 L) PROGESTERONE KIT by Radioassay Systems Laboratories, Inc. — Product Code JLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1980
Date Received
January 18, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Progesterone
Device Class
Class I
Regulation Number
862.1620
Review Panel
CH
Submission Type

Other clearances by Radioassay Systems Laboratories, Inc.

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  • K831855 — HATCH KIT (July 28, 1983)
  • K802195 — DEHYDROEPIANDROSTERONE SULFATE KIT RIA (October 23, 1980)
  • K791999 — (125I) TESTOSTERONE KIT (October 30, 1979)
  • K791740 — SERUM 11-DESOXYCORTISOL I AS TRACER (September 27, 1979)
  • K791651 — TOTAL ESTROGENS KIT BY RIA (September 27, 1979)
  • K791652 — ESTRADIOL KIT BY RIA (September 27, 1979)
  • K791835 — CORALENT COAT 125I CORTISOL RADIOIMM. (September 27, 1979)

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  • K951630 — AURAFLEX PROGESTERONE 150TEST PACK (May 8, 1995)