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510(k) K823014

DIGOXIN KIT by Pcl-Ria, Inc. — Product Code DPB

K823014 is an FDA 510(k) premarket notification submitted by Pcl-Ria, Inc. for the device "DIGOXIN KIT". The FDA issued a decision of Substantially Equivalent on November 1, 1982. The device falls under product code DPB (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.), a Class II device regulated under 21 CFR 862.3320. Pcl-Ria, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1982
Date Received
October 13, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.
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)
  • 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)
  • K810741 — LUTEINIZING HORMONE (March 31, 1981)

Other clearances for product code DPB

  • K853021 — OPTIMATE DIGOXIN TEST (August 7, 1985)
  • K821811 — 125I DIGOXIN RADIOIMMUNOASSAY KIT (July 2, 1982)
  • K820274 — DIGOXIN RADIOIMMUNOASSAY (February 23, 1982)
  • K792153 — DIGOXIN RADIOIMMUNOASSAY SYSTEM (November 13, 1979)
  • K790602 — RIA, DIGNXIN-125-I (July 30, 1979)
  • K790540 — RIA TEST KIT, CENTRIA DIGOXIN (April 23, 1979)
  • K772306 — 125I DIGOXIN TEST SET (December 22, 1977)
  • K771525 — 125 I DIGOXIN RIA KIT (October 14, 1977)
  • K760883 — DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY (November 19, 1976)

FDA data resources