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510(k) K022021

VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT by Vital Scientific N.V. — Product Code GFO

K022021 is an FDA 510(k) premarket notification submitted by Vital Scientific N.V. for the device "VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT". The FDA issued a decision of Substantially Equivalent on November 1, 2002. The device falls under product code GFO (Activated Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Vital Scientific N.V. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2002
Date Received
June 20, 2002
Clearance Type
Traditional
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 Vital Scientific N.V.

  • K021976 — FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON (October 25, 2002)
  • K022046 — VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG CO (July 23, 2002)
  • K020840 — VITAL SCIENTIFIC PT WITH CALCIUM (May 15, 2002)
  • K973628 — VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA (March 13, 1998)

Other clearances for product code GFO

  • K253957 — HemosIL Silica Clotting Time (January 9, 2026)
  • 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)
  • 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)

FDA data resources