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510(k) K874379

CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY by Cytotech, Inc. — Product Code CZY

K874379 is an FDA 510(k) premarket notification submitted by Cytotech, Inc. for the device "CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on November 25, 1987. The device falls under product code CZY (Complement C1s, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Cytotech, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1987
Date Received
October 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C1s, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

Other clearances by Cytotech, Inc.

  • K882829 — CIRCULATING IMMUNE COMPLEXES CONTROLS (August 4, 1988)
  • 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)
  • K860493 — CYTOTECH CMV IGG EIA (May 20, 1986)

FDA data resources