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510(k) K011780

K-ASSAY C1-INA by Kamiya Biomedical Co. — Product Code DBA

K011780 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY C1-INA". The FDA issued a decision of Substantially Equivalent on July 25, 2001. The device falls under product code DBA (Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5250. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2001
Date Received
June 7, 2001
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 Kamiya Biomedical Co.

  • K192727 — K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) (May 20, 2020)
  • K121232 — K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR (May 24, 2012)
  • K093137 — K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL (September 28, 2010)
  • K091486 — K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (April 29, 2010)
  • K050944 — K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET (December 23, 2005)
  • K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (December 10, 2004)
  • K030687 — K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C (June 27, 2003)
  • K023828 — K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULT (February 4, 2003)
  • K023853 — K-ASSAY LP(A) CONTROLS (December 13, 2002)
  • K022486 — K-ASSAY HS-CRP CONTROLS (August 14, 2002)

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)
  • 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)
  • K872426 — CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY (July 23, 1987)
  • K821898 — ORTHO CLASSICAL PATHWAY COMPL. TEST (July 16, 1982)

FDA data resources