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510(k) K964298

N-ASSAY TIA MULTI V-NL by Crestat Diagnostics, Inc. — Product Code CZW

K964298 is an FDA 510(k) premarket notification submitted by Crestat Diagnostics, Inc. for the device "N-ASSAY TIA MULTI V-NL". The FDA issued a decision of Substantially Equivalent on July 14, 1997. The device falls under product code CZW (Complement C3, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Crestat Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1997
Date Received
October 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C3, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

Other clearances by Crestat Diagnostics, Inc.

  • K980883 — N-ASSAY GLU-UL (September 3, 1998)
  • K981276 — N-ASSAY L D-BIL (May 1, 1998)
  • K981289 — N-ASSAY L T-BIL (April 27, 1998)
  • K980902 — N-ASSAY L AST/GOT (March 26, 1998)
  • K980900 — N-ASSAY CPK-L (March 26, 1998)
  • K972257 — N-ASSAY TIA ANTITHROMBIN III TEST KIT (October 20, 1997)
  • K971985 — N-ASSAY TIA PLASMINOGEN TEST KIT (October 20, 1997)
  • K964292 — N-ASSAY TIA APO A1 TEST KIT (August 1, 1997)
  • K964294 — N-ASSAY TIA APO A1/B MULTI CALIBRATOR (August 1, 1997)
  • K964296 — N-ASSAY TIA APO B TEST KIT (August 1, 1997)

Other clearances for product code CZW

  • K100179 — SPAPLUS (August 13, 2010)
  • K063150 — COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL (March 19, 2007)
  • K061852 — DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL (September 22, 2006)
  • K050665 — N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) (May 2, 2005)
  • K042494 — VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMA (October 19, 2004)
  • K032796 — IBL C3D-CIC EIA TEST (January 13, 2004)
  • K032035 — SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C (August 7, 2003)
  • K012361 — TINA-QUANT COMPLEMENT C3C TEST SYSTEM (November 29, 2001)
  • K010326 — WAKO AUTOKIT C3 (June 25, 2001)
  • K000469 — RANDOX COMPLEMENT C3 (March 27, 2000)

FDA data resources