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510(k) K781335

DIGOXIN RIA (PEG) KIT by Ortho Diagnostics, Inc. — Product Code DOG

K781335 is an FDA 510(k) premarket notification submitted by Ortho Diagnostics, Inc. for the device "DIGOXIN RIA (PEG) KIT". The FDA issued a decision of Substantially Equivalent on August 31, 1978. The device falls under product code DOG (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol), a Class II device regulated under 21 CFR 862.3320. Ortho Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1978
Date Received
August 2, 1978
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 Ortho Diagnostics, Inc.

  • K802404 — ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE (October 23, 1980)
  • K801507 — ANTIGEN CONTROL CELLS (August 20, 1980)
  • K800357 — BI-LEVEL ASSAYED CARD. DRUG CONT., I,II (April 16, 1980)
  • K800310 — ORTHO ANTISERA CONTROL (March 5, 1980)
  • K791791 — ORTHO ANTIBODY ENHANCEMENT SOLUTION (October 11, 1979)
  • K791301 — ORTHO TSH RIA KIT (September 24, 1979)
  • K790813 — MULTECON BLOOD GAS CONTROL (June 28, 1979)
  • K782166 — SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 (April 4, 1979)
  • K782063 — PREGNANCY, SENSIDEX TUBE TEST (April 4, 1979)
  • K781638 — RUBINDEX*DIRECT SYSTEM (December 20, 1978)

Other clearances for product code DOG

  • K810477 — DCA DIGOX-SYN RIA TEST (March 11, 1981)
  • K803045 — IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. (December 22, 1980)
  • K760709 — EMIT DIGOKIN ASSAY (October 21, 1976)
  • K760416 — DATA-TOPE SYSTEM DIGOXIN RIA (August 23, 1976)

FDA data resources