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510(k) K913080

OPUS(R) ANTI CMV-M by Pb Diagnostics, Inc. — Product Code LKQ

K913080 is an FDA 510(k) premarket notification submitted by Pb Diagnostics, Inc. for the device "OPUS(R) ANTI CMV-M". The FDA issued a decision of Substantially Equivalent on October 28, 1991. The device falls under product code LKQ (Antibody Igm,If, Cytomegalovirus Virus), a Class II device regulated under 21 CFR 866.3175. Pb Diagnostics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1991
Date Received
July 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibody Igm,If, Cytomegalovirus Virus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

Other clearances by Pb Diagnostics, Inc.

  • K925703 — OPUS SEROLOGY CONTROLS (April 8, 1993)
  • K921523 — OPUS(R) TOXO-G TEST SYSTEM (September 14, 1992)
  • K915870 — OPUS RUBELLA TEST SYSTEM (March 23, 1992)

Other clearances for product code LKQ

  • K100433 — IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUS (May 13, 2010)
  • K972884 — ACCURUN 146 CMV IGM POSITIVE CONTROL (August 22, 1997)
  • K933549 — VIDAS CMV IGM ASSAY (August 2, 1994)
  • K922580 — BARTELS CYTOMEGALOVIRUS IGM EIA (April 8, 1993)
  • K914789 — ELISA CMV IGM (March 4, 1992)
  • K900743 — CMV-IGM IFA TEST SYSTEM (April 26, 1990)
  • K893465 — CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) (July 25, 1989)
  • K893466 — CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) (July 14, 1989)
  • K872881 — ABBOTT CMV-M EIA KIT (May 13, 1988)
  • K872942 — IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 (January 11, 1988)

FDA data resources