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510(k) K863488

ENZYGNOST ANTI-CMV IGG TEST by Behring Diagnostics, Inc. — Product Code GQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1987
Date Received
September 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Cf, Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

Other clearances by Behring Diagnostics, Inc.

  • K973832 — OPUS HLH CONTROLS (October 27, 1997)
  • K972929 — N ANTISERUM TO HUMAN ALBUMIN (October 20, 1997)
  • K972840 — N ANTISERUM TO HUMAN TRANSFERRIN (October 17, 1997)
  • K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM (September 12, 1997)
  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K972116 — VON WILLEBRAND REAGENT (July 25, 1997)
  • K972011 — OPUS ETHANOL (July 22, 1997)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (June 25, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (June 25, 1997)
  • K964595 — OPUS PSA TEST SYSTEM (June 24, 1997)

Other clearances for product code GQI

  • K951800 — CMV IGG HUMAN SERUM CONTROLS (November 16, 1995)
  • K952254 — ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS (November 16, 1995)
  • K942171 — CMV EARLY ANTIGEN TEST (June 30, 1994)
  • K883102 — VIRGO (R) CMV-IGG ELISA (February 8, 1989)
  • K875159 — DETECTADOT SYSTEM 2000 CMV IGG TEST (May 6, 1988)
  • K864420 — CMV MICROASSAY (February 2, 1987)
  • K861123 — THE GOLDEN QUAD TEST (CMV) (February 2, 1987)
  • K862705 — CYTOMEGALOVIRUS IGG EIA TEST KIT (October 1, 1986)
  • K853989 — COR DOT CMV (June 13, 1986)
  • K860493 — CYTOTECH CMV IGG EIA (May 20, 1986)