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510(k) K014008

HEMOCHRON JR. CITRATE APTT CUVETTE by Itc, Inc. — Product Code GFO

K014008 is an FDA 510(k) premarket notification submitted by Itc, Inc. for the device "HEMOCHRON JR. CITRATE APTT CUVETTE". The FDA issued a decision of Substantially Equivalent on January 24, 2002. The device falls under product code GFO (Activated Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2002
Date Received
December 5, 2001
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

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  • 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)
  • 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