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510(k) K780889

DIGOXIN STANDARDS IN HUMAN SERUM by Pcl-Ria, Inc. — Product Code DMP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1978
Date Received
May 31, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Digoxin Control Serum, Ria
Device Class
Class I
Regulation Number
862.3280
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 DMP

  • K973973 — ELECSYS CALLCHECK DIGOXIN (November 4, 1997)
  • K953393 — TOX PERFECT A TUBE (October 6, 1995)
  • K770411 — DIGI TROL TM-RX & DIGI TROL TM-TX (March 16, 1977)