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510(k) K832452

ANDROSTENEDIONE TEST SET 125I by Wien Laboratories, Inc. — Product Code CIZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
July 25, 1983
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 Wien Laboratories, Inc.

  • K912850 — SHBG (August 12, 1991)
  • K834246 — PROGESTERONE TEST SET 125I 17-OH (February 4, 1984)
  • K823200 — 125 I-DEHYDROEPIANDROSTERONE SULFATE (November 29, 1982)
  • K821652 — DOXEPIN TRI-CY TEST SET (June 14, 1982)
  • K821653 — PROTRIPTYLINE TRI-CY TEST SET (June 14, 1982)
  • K802728 — 125I-TESTOSTERONE TEST SET (December 11, 1980)
  • K792041 — DHEA-SULFATE TEST SET (October 30, 1979)
  • K781834 — TEST SET, 125 I-DIGOXIN (January 3, 1979)
  • K781599 — I-ESTRIOL TEST SET (October 17, 1978)
  • K772306 — 125I DIGOXIN TEST SET (December 22, 1977)

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)
  • K801729 — ANDROSTENEDIONE RADIOIMMUNOASSAY KIT (October 31, 1980)