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510(k) K772306

125I DIGOXIN TEST SET by Wien Laboratories, Inc. — Product Code DPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1977
Date Received
December 15, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Wien Laboratories, Inc.

  • K912850 — SHBG (August 12, 1991)
  • K834246 — PROGESTERONE TEST SET 125I 17-OH (February 4, 1984)
  • K832452 — ANDROSTENEDIONE TEST SET 125I (September 12, 1983)
  • 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)

Other clearances for product code DPB

  • K853021 — OPTIMATE DIGOXIN TEST (August 7, 1985)
  • K823014 — DIGOXIN KIT (November 1, 1982)
  • K821811 — 125I DIGOXIN RADIOIMMUNOASSAY KIT (July 2, 1982)
  • K820274 — DIGOXIN RADIOIMMUNOASSAY (February 23, 1982)
  • K792153 — DIGOXIN RADIOIMMUNOASSAY SYSTEM (November 13, 1979)
  • K790602 — RIA, DIGNXIN-125-I (July 30, 1979)
  • K790540 — RIA TEST KIT, CENTRIA DIGOXIN (April 23, 1979)
  • K771525 — 125 I DIGOXIN RIA KIT (October 14, 1977)
  • K760883 — DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY (November 19, 1976)