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510(k) K862649

CYTOTECH CIC ENZYME IMMUNOASSAY by Cytotech, Inc. — Product Code DAK

K862649 is an FDA 510(k) premarket notification submitted by Cytotech, Inc. for the device "CYTOTECH CIC ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on September 4, 1986. The device falls under product code DAK (Complement C1q, 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
September 4, 1986
Date Received
July 11, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C1q, 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)
  • 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)
  • K860493 — CYTOTECH CMV IGG EIA (May 20, 1986)

Other clearances for product code DAK

  • K031563 — BINDAZYME CLQ CIC EIA KIT (September 10, 2003)
  • K032254 — IBL C1Q-CIC CIA TEST (August 29, 2003)
  • K012576 — CIC-C1Q EIA (January 29, 2002)
  • K973203 — THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODI (September 30, 1998)
  • K972873 — IMMUSTRIP HAMA IGG (March 17, 1998)
  • K951968 — HUMAN C1Q RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K914388 — C1 RID KIT (October 28, 1991)
  • K882829 — CIRCULATING IMMUNE COMPLEXES CONTROLS (August 4, 1988)
  • K860996 — SANASSAY IC TEST (March 30, 1987)
  • K864312 — IC MICROASSAY (January 9, 1987)

FDA data resources