Home / 510(k) Clearances / K915850

510(k) K915850

OPUS MYOGLOBIN TEST SYSTEM by Pb Diagnostic Systems, Inc. — Product Code DDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1992
Date Received
December 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Myoglobin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5680
Review Panel
IM
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)
  • K935229 — OPUS DIGITOXIN (December 22, 1993)
  • 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)

Other clearances for product code DDR

  • K231832 — Access Myoglobin (September 18, 2023)
  • K123785 — DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET (June 7, 2013)
  • K122599 — ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR (October 3, 2012)
  • K083260 — ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN (October 16, 2009)
  • K080481 — ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CA (February 20, 2009)
  • K061683 — TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM (July 21, 2006)
  • K042924 — ARCHITECT STAT MYO IMMUNOASSAY (January 24, 2005)
  • K042982 — QUANTEX MYOGLOBIN (December 22, 2004)
  • K033300 — VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERI (November 5, 2003)
  • K021229 — MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973 (June 28, 2002)