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510(k) K771255

CEBTRIA DIGOXIN RIA by Union Carbide Corp. — Product Code DON

K771255 is an FDA 510(k) premarket notification submitted by Union Carbide Corp. for the device "CEBTRIA DIGOXIN RIA". The FDA issued a decision of Substantially Equivalent on August 25, 1977. The device falls under product code DON (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.), a Class II device regulated under 21 CFR 862.3320. Union Carbide Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1977
Date Received
July 12, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Union Carbide Corp.

  • K830337 — MARK III OXYGEN WALKER SYS-LOW PRESS (March 17, 1983)
  • K820836 — MARK III OXYGEN WALKER SYSTEM (April 15, 1982)
  • K820535 — LASER GAS MIXTURES (March 31, 1982)
  • K812536 — LINDE MARK II (September 23, 1981)
  • K810732 — LINDE MARK II OXYGEN RESERV. TYPE OR-4 (March 27, 1981)
  • K810596 — CENTRIFI CHEM SYSTEM 400 ANALYZER (March 17, 1981)
  • K810129 — CENTRIFICHEM SYSTEM 500 (February 2, 1981)
  • K803216 — CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT (January 9, 1981)
  • K802741 — CENTRIFICHEM COMB. SERUM-BASED CALIB. (December 10, 1980)
  • K802520 — CENTRIFICHEM PIPETTOR ACCURACY CALIB. (November 12, 1980)

Other clearances for product code DON

  • K902861 — CIBA CORNING ACS DIGOXIN IMMUNOASSAY (September 10, 1990)
  • K881679 — CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY (July 8, 1988)
  • K840461 — MAGIC 125I DIGOXIN RADIOIMMUNOASSAY (March 23, 1984)
  • K830533 — PHASE II DIGOXIN RADIOIMMUNOASSAY KIT (April 5, 1983)
  • K822053 — ZETAPHASE-DIG (July 27, 1982)
  • K821000 — ENZYMUNE-TEST DIGOXIN (April 26, 1982)
  • K810296 — DIGOXIN RIA ASSAY (February 19, 1981)
  • K803075 — DIGOXIN RIABEAD DIAGNOSTIC KIT (December 22, 1980)
  • K791549 — TECHNICON STAR SYSTEM (September 27, 1979)
  • K781660 — RIA, DIGOXIN (October 24, 1978)

FDA data resources