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510(k) K760883

DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY by Nuclear Medical Laboratories, Inc. — Product Code DPB

K760883 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on November 19, 1976. 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. Nuclear Medical Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1976
Date Received
October 21, 1976
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 Nuclear Medical Laboratories, Inc.

  • K852438 — NML TSH IRMA (July 12, 1985)
  • K844583 — TSH-STAT (March 5, 1985)
  • K840466 — NML CORTISOL RIA (March 30, 1984)
  • K840589 — TRI-TUBE RIA (March 9, 1984)
  • K832892 — MODIFIED CHORIO-SHURE (October 28, 1983)
  • K832002 — NML-5010/5020 MULTI-DETECTOR SYSTEM (August 8, 1983)
  • K823679 — NML 6000 CT (January 7, 1983)
  • K823053 — NML-TETRA-TUBE RIA (November 10, 1982)
  • K822298 — DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI (September 2, 1982)
  • K820523 — CHORIO-QUANT (March 15, 1982)

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)
  • 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)

FDA data resources