Home / 510(k) Clearances / K780498

510(k) K780498

CBR-DIGOXIN ANTISERUM by Clinical Bioresearch — Product Code DKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1978
Date Received
March 28, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Digoxin
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Clinical Bioresearch

  • K780707 — T4-RIA KIT (June 14, 1978)
  • K780499 — CBR-T3RIA KIT (May 4, 1978)
  • K780500 — CBR-T3 UPTAKE KIT (May 3, 1978)

Other clearances for product code DKA

  • K934003 — STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY (November 22, 1994)
  • K780316 — RABBIT ANTIBODY TO DIGOXIN (March 17, 1978)