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510(k) K860493

CYTOTECH CMV IGG EIA by Cytotech, Inc. — Product Code GQI

K860493 is an FDA 510(k) premarket notification submitted by Cytotech, Inc. for the device "CYTOTECH CMV IGG EIA". The FDA issued a decision of Substantially Equivalent on May 20, 1986. The device falls under product code GQI (Antiserum, Cf, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Cytotech, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1986
Date Received
February 10, 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 Cytotech, Inc.

  • K882829 — CIRCULATING IMMUNE COMPLEXES CONTROLS (August 4, 1988)
  • K874379 — CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY (November 25, 1987)
  • K873249 — ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS (September 22, 1987)
  • K872426 — CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY (July 23, 1987)
  • K871801 — CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT (June 9, 1987)
  • K864315 — CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY (February 2, 1987)
  • K862838 — CYTOTECH HSV IGG ENZYME IMMUNOASSAY (December 9, 1986)
  • K863363 — CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY (November 13, 1986)
  • K862649 — CYTOTECH CIC ENZYME IMMUNOASSAY (September 4, 1986)

Other clearances for product code GQI

  • K952254 — ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS (November 16, 1995)
  • K951800 — CMV IGG HUMAN SERUM CONTROLS (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)
  • K863488 — ENZYGNOST ANTI-CMV IGG TEST (July 20, 1987)
  • K861123 — THE GOLDEN QUAD TEST (CMV) (February 2, 1987)
  • K864420 — CMV MICROASSAY (February 2, 1987)
  • K862705 — CYTOMEGALOVIRUS IGG EIA TEST KIT (October 1, 1986)
  • K853989 — COR DOT CMV (June 13, 1986)

FDA data resources