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510(k) K935229

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

K935229 is an FDA 510(k) premarket notification submitted by Pb Diagnostic Systems, Inc. for the device "OPUS DIGITOXIN". The FDA issued a decision of Substantially Equivalent on December 22, 1993. The device falls under product code DPG (Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.), a Class II device regulated under 21 CFR 862.3300. Pb Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K933066 — OPUS ESTRADIOL (September 8, 1993)
  • K933675 — OPUS TOTAL CK (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)

FDA data resources