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510(k) K842960

ANDROSTENEDIONE BY RIA by Radioassay Systems Laboratories, Inc. — Product Code CIZ

K842960 is an FDA 510(k) premarket notification submitted by Radioassay Systems Laboratories, Inc. for the device "ANDROSTENEDIONE BY RIA". The FDA issued a decision of Substantially Equivalent on September 27, 1984. The device falls under product code CIZ (Radioimmunoassay, Androstenedione), a Class I device regulated under 21 CFR 862.1075. Radioassay Systems Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1984
Date Received
July 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Androstenedione
Device Class
Class I
Regulation Number
862.1075
Review Panel
CH
Submission Type

Other clearances by Radioassay Systems Laboratories, Inc.

  • K862204 — RSL (125I) ALDOSTERONE KIT (September 25, 1986)
  • 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)
  • K791728 — RSL'S ASSAY PROCEDURE QUANTITATION (September 27, 1979)

Other clearances for product code CIZ

  • K963002 — ACTIVE ANDROSTENEDIONE EIA (August 16, 1996)
  • K954755 — COAT-A-COUNT DIRECT ANDROSTENEDIONE (November 29, 1995)
  • K934751 — ACTIVE ANDROSTANEDIOL GLUCURONIDE (January 10, 1994)
  • K860559 — ANDROSTENEDIONE 125I KIT BY RIA (March 14, 1986)
  • K854673 — DSL ANDROSTENEDIONE RIA (DSL # 4200) (January 22, 1986)
  • K854650 — DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) (December 13, 1985)
  • K844398 — COAT-A-COUNT ANDROSTENEDIONE RIA KIT (December 10, 1984)
  • K832452 — ANDROSTENEDIONE TEST SET 125I (September 12, 1983)
  • K801729 — ANDROSTENEDIONE RADIOIMMUNOASSAY KIT (October 31, 1980)

FDA data resources