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510(k) K891337

THROMBOSCREEN APTT REAGENT by Pacific Hemostasis — Product Code GFO

K891337 is an FDA 510(k) premarket notification submitted by Pacific Hemostasis for the device "THROMBOSCREEN APTT REAGENT". The FDA issued a decision of Substantially Equivalent on April 21, 1989. The device falls under product code GFO (Activated Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Pacific Hemostasis has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1989
Date Received
March 10, 1989
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 Pacific Hemostasis

  • K000679 — THROMBOSTRATE CONTROL PLASMAS (March 24, 2000)
  • K994100 — PACIFIC HEMOSTASIS THROMBOPLASTIN D (February 18, 2000)
  • K992130 — PACIFIC HEMOSTASIS THROMBOSCREEN 400C (September 3, 1999)
  • K992279 — HEPARIN CONTROL PLASMA LEVEL 2 (August 26, 1999)
  • K992278 — HEPARIN CONTROL PLASMA LEVEL 1 (August 26, 1999)
  • K991321 — PACIFIC HEMOSTASIS THROMBOSCREEN 200 (June 21, 1999)
  • K990046 — PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA (February 17, 1999)
  • K984129 — COAGULATION CONTROL LEVEL 1 (NORMAL) (December 1, 1998)
  • K984131 — COAGULATION CONTROL LEVEL 3 (ABNORMAL) (December 1, 1998)
  • K984130 — COAGULATION CONTROL LEVEL 2 (ABNORMAL) (December 1, 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)
  • 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)

FDA data resources