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510(k) K790602

RIA, DIGNXIN-125-I by Endocrine-Metabolic Center — Product Code DPB

K790602 is an FDA 510(k) premarket notification submitted by Endocrine-Metabolic Center for the device "RIA, DIGNXIN-125-I". The FDA issued a decision of Substantially Equivalent on July 30, 1979. 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. Endocrine-Metabolic Center has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1979
Date Received
March 27, 1979
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 Endocrine-Metabolic Center

  • K821131 — RADIOIMMUNOASSAY PARATHYROID HORMONE MID (June 2, 1982)
  • K811993 — RADIOIMMUNOASSAY, FOLLICLE STIMULATING (August 3, 1981)
  • K811994 — RADIOIMMUNOASSAY LUTEINIZING HORMONE (July 27, 1981)
  • K810948 — RADIOIMMUNOASSAY THYROID STIM. HORM. KIT (April 17, 1981)
  • K810351 — RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE (February 23, 1981)
  • K800187 — EMC-M-175, THYROXINE - 100 TUBES (February 13, 1980)
  • K800188 — EMC-M-180, T3 UPTAKE - 100 TUBES (February 13, 1980)
  • K790630 — RIA, INSULIN, DOUBLE ANTIBODY (July 24, 1979)

Other clearances for product code DPB

  • K853021 — OPTIMATE DIGOXIN TEST (August 7, 1985)
  • K823014 — DIGOXIN KIT (November 1, 1982)
  • K821811 — 125I DIGOXIN RADIOIMMUNOASSAY KIT (July 2, 1982)
  • K820274 — DIGOXIN RADIOIMMUNOASSAY (February 23, 1982)
  • K792153 — DIGOXIN RADIOIMMUNOASSAY SYSTEM (November 13, 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