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510(k) K792153

DIGOXIN RADIOIMMUNOASSAY SYSTEM by Radioimmunoassay, Inc. — Product Code DPB

K792153 is an FDA 510(k) premarket notification submitted by Radioimmunoassay, Inc. for the device "DIGOXIN RADIOIMMUNOASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 13, 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. Radioimmunoassay, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1979
Date Received
October 26, 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 Radioimmunoassay, Inc.

  • K802135 — TESTOSTERONE RADIOIMMUNOASSY KIT (October 10, 1980)
  • K800107 — FOLLICLE STIMULATING HORMONE (February 13, 1980)
  • K800106 — LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS (February 13, 1980)
  • K792539 — TRIIODOTHYRONINE RIA SYSTEM (January 16, 1980)
  • K792154 — THYROID STIMULATING HORMONE (November 13, 1979)
  • K792036 — CORTISOL RADIOIMMUNOASSAY SYSTEM (October 30, 1979)
  • K780672 — 125 I-T4 RIA REAGENT (June 6, 1978)
  • K780671 — 125 I-T3 UPTAKE REAGENT (June 6, 1978)

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)
  • 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