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510(k) K965113

N-ASSAY TIA FIBRINOGEN TEST KIT by Crestat Diagnostics, Inc. — Product Code KQJ

K965113 is an FDA 510(k) premarket notification submitted by Crestat Diagnostics, Inc. for the device "N-ASSAY TIA FIBRINOGEN TEST KIT". The FDA issued a decision of Substantially Equivalent on April 16, 1997. The device falls under product code KQJ (System, Fibrinogen Determination), a Class II device regulated under 21 CFR 864.7340. Crestat Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1997
Date Received
December 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Fibrinogen Determination
Device Class
Class II
Regulation Number
864.7340
Review Panel
HE
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 KQJ

  • K251968 — HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (July 24, 2025)
  • K073367 — HEMOSIL FIBRINOGEN-C (December 27, 2007)
  • K050928 — DADE THROMBIN REAGENT (June 29, 2005)
  • K971858 — SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) (October 9, 1997)
  • K970189 — FIF TM (May 21, 1997)
  • K934326 — MULTIFIBREN U (April 19, 1994)
  • K931721 — IL TEST FIBRINOGEN-C (August 13, 1993)
  • K922416 — FIBRINOGEN RID TEST KIT (March 9, 1993)
  • K925988 — MULTIFIBREN (March 1, 1993)
  • K923593 — HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS (September 22, 1992)

FDA data resources