Home / 510(k) Clearances / K771877

510(k) K771877

DIGOXIN RIA KIT by Antibodies, Inc. — Product Code DNJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1977
Date Received
October 4, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Antibodies, Inc.

  • K890774 — GIARDEIA(TM) (April 4, 1989)
  • K843590 — DETECT-A-STREP (October 30, 1984)
  • K822892 — CORTISOL RIA KIT (November 1, 1982)
  • K812749 — ULTRA-DIG (October 19, 1981)
  • K812314 — CRITHIDNA ANTI-DNA TEST KIT (September 1, 1981)
  • K802877 — AMIKACIN RIA KIT (December 19, 1980)
  • K800743 — TOBRAMYCIN RIA KIT (April 16, 1980)
  • K791217 — TSH RIA KIT (September 4, 1979)
  • K781656 — NEPHELRATE ANTISERUMS, IGG (November 8, 1978)
  • K781655 — NEPHELRATE ANTISERUMS 1GA (November 8, 1978)

Other clearances for product code DNJ

  • K771533 — DIGOXIN RIA KIT (August 25, 1977)