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510(k) K253957

HemosIL Silica Clotting Time by Instrumentation Laboratory (IL) Co. — Product Code GFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2026
Date Received
December 10, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

Other clearances by Instrumentation Laboratory (IL) Co.

  • K251968 — HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (July 24, 2025)
  • 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 GFO

  • K193556 — Cryocheck Hex LA (October 23, 2020)
  • K160445 — HemosIL Silica Clotting Time (March 16, 2016)
  • K053111 — STA-CEPHASCREEN KIT (May 4, 2006)
  • K060688 — HEMOSIL SYNTHASIL (April 13, 2006)
  • K050221 — HEMOSIL SILICA CLOTTING TIME (March 30, 2005)
  • K022021 — VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT (November 1, 2002)
  • K014028 — CARESIDE APTT (February 8, 2002)
  • K014008 — HEMOCHRON JR. CITRATE APTT CUVETTE (January 24, 2002)
  • K992712 — SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 (December 6, 1999)
  • K992711 — SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 (December 6, 1999)