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510(k) K791740

SERUM 11-DESOXYCORTISOL I AS TRACER by Radioassay Systems Laboratories, Inc. — Product Code JKB

K791740 is an FDA 510(k) premarket notification submitted by Radioassay Systems Laboratories, Inc. for the device "SERUM 11-DESOXYCORTISOL I AS TRACER". The FDA issued a decision of Substantially Equivalent on September 27, 1979. The device falls under product code JKB (Radioimmunoassay, Compound S (11-Deoxycortisol)), a Class I device regulated under 21 CFR 862.1185. 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
September 10, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Compound S (11-Deoxycortisol)
Device Class
Class I
Regulation Number
862.1185
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)
  • K791652 — ESTRADIOL KIT BY RIA (September 27, 1979)
  • K791651 — TOTAL ESTROGENS KIT BY RIA (September 27, 1979)
  • K791835 — CORALENT COAT 125I CORTISOL RADIOIMM. (September 27, 1979)

FDA data resources