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510(k) K251968

HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL by Instrumentation Laboratory (IL) Co. — Product Code KQJ

K251968 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory (IL) Co. for the device "HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL". The FDA issued a decision of Substantially Equivalent on July 24, 2025. The device falls under product code KQJ (System, Fibrinogen Determination), a Class II device regulated under 21 CFR 864.7340. Instrumentation Laboratory (IL) Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2025
Date Received
June 26, 2025
Clearance Type
Special
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 Instrumentation Laboratory (IL) Co.

  • K260551 — HemosIL Factor V Leiden (APC Resistance V) (March 20, 2026)
  • K253957 — HemosIL Silica Clotting Time (January 9, 2026)
  • K243374 — HemosIL CL HIT-IgG(PF4-H) (January 28, 2025)
  • K242127 — ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP (August 16, 2024)

Other clearances for product code KQJ

  • 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)
  • K965113 — N-ASSAY TIA FIBRINOGEN TEST KIT (April 16, 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