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510(k) K014028

CARESIDE APTT by Careside Hemotology, Inc. — Product Code GFO

K014028 is an FDA 510(k) premarket notification submitted by Careside Hemotology, Inc. for the device "CARESIDE APTT". The FDA issued a decision of Substantially Equivalent on February 8, 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
February 8, 2002
Date Received
December 6, 2001
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

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  • 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)
  • 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