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510(k) K935229

OPUS DIGITOXIN by Pb Diagnostic Systems, Inc. — Product Code DPG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1993
Date Received
November 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Device Class
Class II
Regulation Number
862.3300
Review Panel
TX
Submission Type

Other clearances by Pb Diagnostic Systems, Inc.

  • K940507 — OPUS FT4 TEST SYSTEM (July 28, 1994)
  • K934762 — OPUS PROCAINAMIDE TEST SYSTEM (July 20, 1994)
  • K933389 — OPUS CMV-G (June 28, 1994)
  • K934137 — OPUS(R) SEROLOGY CONTROLS, MODIFICATION (March 7, 1994)
  • K934705 — OPUS NAPA (November 22, 1993)
  • K933675 — OPUS TOTAL CK (September 8, 1993)
  • K933066 — OPUS ESTRADIOL (September 8, 1993)
  • K932279 — OPUS(R) TOTAL B-HCG TEST SYSTEM (July 8, 1993)
  • K926131 — OPUS MAGNUM ANALYZER (June 7, 1993)
  • K924957 — OPUS(R) VANCOMYCIN (December 11, 1992)

Other clearances for product code DPG

  • K812129 — COAT-A-COUNT DIGITOXIN RIA KIT (August 13, 1981)
  • K780075 — RIALYZE DIGOXIN (February 28, 1978)