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510(k) K862838

CYTOTECH HSV IGG ENZYME IMMUNOASSAY by Cytotech, Inc. — Product Code GCO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1986
Date Received
July 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Mirror
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
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)
  • K863363 — CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY (November 13, 1986)
  • K862649 — CYTOTECH CIC ENZYME IMMUNOASSAY (September 4, 1986)
  • K860493 — CYTOTECH CMV IGG EIA (May 20, 1986)

Other clearances for product code GCO

  • K862717 — HAND MIRROR (ENDOSCOPE) (July 30, 1986)
  • K790340 — DELTA-ROL (April 12, 1979)