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510(k) K821000

ENZYMUNE-TEST DIGOXIN by Icl Scientific — Product Code DON

K821000 is an FDA 510(k) premarket notification submitted by Icl Scientific for the device "ENZYMUNE-TEST DIGOXIN". The FDA issued a decision of Substantially Equivalent on April 26, 1982. 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. Icl Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1982
Date Received
April 8, 1982
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 Icl Scientific

  • K883942 — HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL (November 10, 1988)
  • K843565 — KOVA TROL I,II, III HUMAN URINE-DRIED (October 5, 1984)
  • K833761 — THERAPEUTIC DRUG CONTROL (January 13, 1984)
  • K832823 — ENZYMUNE-TEST TSH (October 14, 1983)
  • K831383 — EVENT-TEST SLIDE (June 22, 1983)
  • K823199 — ENZYME-TEST DIGOXIN (November 29, 1982)
  • K822346 — HISTIMUNE ENZYME-ANA TEST (October 8, 1982)
  • K822777 — THERAPEUTIC DRUG CONTROL (October 8, 1982)
  • K822465 — ENZYMUNE SYSTEM I (September 14, 1982)
  • K821374 — ENZYMUNE-TEST INSULIN (May 28, 1982)

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)
  • 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)
  • K780475 — DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT (April 24, 1978)

FDA data resources