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510(k) K780316

RABBIT ANTIBODY TO DIGOXIN by Pcl-Ria, Inc. — Product Code DKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1978
Date Received
February 24, 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 Pcl-Ria, Inc.

  • K830526 — B-GCG SYSTEM BY RIA (April 5, 1983)
  • K823014 — DIGOXIN KIT (November 1, 1982)
  • K822935 — THYROID STIMULATING HORMONE (November 1, 1982)
  • K822612 — T3 UPTAKE KITS (September 30, 1982)
  • K820886 — THYROXINE T4 KIT (April 16, 1982)
  • K820358 — FOLLICLE STIMULATING HORMONE KIT (March 26, 1982)
  • K820357 — LUTEINIZING HORMONE KIT (March 25, 1982)
  • K812666 — THYROXINE (T4) 125I (October 2, 1981)
  • K810867 — FOLLICLE STIMULATING HORMONE (FSH) (April 14, 1981)
  • K810852 — FOLLICLE STIMULATING HORMONE ANTISERUM (April 8, 1981)

Other clearances for product code DKA

  • K934003 — STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY (November 22, 1994)
  • K780498 — CBR-DIGOXIN ANTISERUM (April 5, 1978)