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510(k) K760416

DATA-TOPE SYSTEM DIGOXIN RIA by Dade, Baxter Travenol Diagnostics, Inc. — Product Code DOG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1976
Date Received
August 9, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Dade, Baxter Travenol Diagnostics, Inc.

  • K800296 — WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 (March 5, 1980)
  • K792606 — WHOLE BLOOD PLATELET CONTROL NORMAL, (February 13, 1980)
  • K792723 — BLOOD FLUID FILTERS (January 21, 1980)
  • K792607 — T3 UPTAKE (T3U) REAGENTS (January 16, 1980)
  • K792443 — TSH RADIOIMMUNOASSAY (December 27, 1979)
  • K792442 — FERRITIN RADIOIMMUNOASSAY (December 18, 1979)
  • K791922 — HARLECO BRAND CLINICARD LIPASE TEST SET (November 27, 1979)
  • K792183 — DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO (November 13, 1979)
  • K790767 — IMMU-TEK AUTOMATIC CENTRIFUGE (May 23, 1979)
  • K790776 — DADE LOW IONIC STRENGTH SOLUITION (LISS) (May 23, 1979)

Other clearances for product code DOG

  • K810477 — DCA DIGOX-SYN RIA TEST (March 11, 1981)
  • K803045 — IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. (December 22, 1980)
  • K781335 — DIGOXIN RIA (PEG) KIT (August 31, 1978)
  • K760709 — EMIT DIGOKIN ASSAY (October 21, 1976)