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510(k) K801729

ANDROSTENEDIONE RADIOIMMUNOASSAY KIT by Diagnostics Biochem Canada, Inc. — Product Code CIZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
July 24, 1980
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 Diagnostics Biochem Canada, Inc.

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  • K864966 — ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE (January 9, 1987)
  • K832297 — HYDROXYPROGESTERONE-17 (September 1, 1983)
  • K781310 — HUMAN CHORIONIC GONADO.-BETA RIA KIT (August 31, 1978)

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)
  • K842960 — ANDROSTENEDIONE BY RIA (September 27, 1984)
  • K832452 — ANDROSTENEDIONE TEST SET 125I (September 12, 1983)