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510(k) K781834

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

K781834 is an FDA 510(k) premarket notification submitted by Wien Laboratories, Inc. for the device "TEST SET, 125 I-DIGOXIN". The FDA issued a decision of Substantially Equivalent on January 3, 1979. The device falls under product code DNL (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.), a Class II device regulated under 21 CFR 862.3320. Wien Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1979
Date Received
October 30, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody 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)
  • K821653 — PROTRIPTYLINE TRI-CY TEST SET (June 14, 1982)
  • K821652 — DOXEPIN TRI-CY TEST SET (June 14, 1982)
  • K802728 — 125I-TESTOSTERONE TEST SET (December 11, 1980)
  • K792041 — DHEA-SULFATE TEST SET (October 30, 1979)
  • K781599 — I-ESTRIOL TEST SET (October 17, 1978)
  • K772306 — 125I DIGOXIN TEST SET (December 22, 1977)

Other clearances for product code DNL

  • K852343 — DIG RADIOIMMUNOASSAY TEST SYSTEM (July 9, 1985)
  • K852291 — TIPSEP DIGOXIN RIA (June 25, 1985)
  • K811212 — DIGOXIN (RIA) KIT (May 21, 1981)
  • K810966 — DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT (April 21, 1981)
  • K802841 — DIGOXIN RADIOIMMUNOASSAY KIT (December 18, 1980)
  • K781495 — RIANEN ASSAY SYSTEM, 125I KIT (September 14, 1978)
  • K772110 — IN VITRO DIGOXIN RIA TEST (November 22, 1977)

FDA data resources