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510(k) K872426

CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY by Cytotech, Inc. — Product Code DBA

K872426 is an FDA 510(k) premarket notification submitted by Cytotech, Inc. for the device "CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on July 23, 1987. The device falls under product code DBA (Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5250. Cytotech, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1987
Date Received
June 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5250
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)
  • 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)

Other clearances for product code DBA

  • K141100 — OPTILITE C1 INACTIVATOR KIT (July 18, 2014)
  • K122304 — HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS (April 15, 2013)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)
  • K011780 — K-ASSAY C1-INA (July 25, 2001)
  • K003747 — C1-INHIBITOR MICROTITER ASSAY DEVICE (March 19, 2001)
  • K965024 — N-ASSAY TIA C1-INACTIVATOR TEST KIT (July 14, 1997)
  • K960257 — N ANTISERUM TO C1 INHIBITOR (August 1, 1996)
  • K951967 — HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K915431 — COMPLEMENT C1 INACTIVATOR KIT (January 17, 1992)
  • K821898 — ORTHO CLASSICAL PATHWAY COMPL. TEST (July 16, 1982)

FDA data resources