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510(k) K984129

COAGULATION CONTROL LEVEL 1 (NORMAL) by Pacific Hemostasis — Product Code GIZ

K984129 is an FDA 510(k) premarket notification submitted by Pacific Hemostasis for the device "COAGULATION CONTROL LEVEL 1 (NORMAL)". The FDA issued a decision of Substantially Equivalent on December 1, 1998. The device falls under product code GIZ (Plasma, Control, Normal), a Class II device regulated under 21 CFR 864.5425. Pacific Hemostasis has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1998
Date Received
November 18, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Control, Normal
Device Class
Class II
Regulation Number
864.5425
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)
  • K992278 — HEPARIN CONTROL PLASMA LEVEL 1 (August 26, 1999)
  • K992279 — HEPARIN CONTROL PLASMA LEVEL 2 (August 26, 1999)
  • K991321 — PACIFIC HEMOSTASIS THROMBOSCREEN 200 (June 21, 1999)
  • K990046 — PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA (February 17, 1999)
  • K984130 — COAGULATION CONTROL LEVEL 2 (ABNORMAL) (December 1, 1998)
  • K984131 — COAGULATION CONTROL LEVEL 3 (ABNORMAL) (December 1, 1998)
  • K972627 — PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND (August 13, 1997)

Other clearances for product code GIZ

  • K060968 — STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; (May 15, 2007)
  • K042941 — DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS (December 2, 2004)
  • K023309 — CONTROL PLASMA N (November 1, 2002)
  • K013708 — REFERENCE CHECK, CATALOG NUMBER-RCN-10 (December 10, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (March 1, 2001)
  • K001256 — CONTROL PLASMA N (May 24, 2000)
  • K973274 — ACCUCOLOR HIGH CALIBRATOR (A3089) (October 31, 1997)
  • K961814 — THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS (August 13, 1996)
  • K941737 — SPECIALTY ASSAYED CONTROL-1 (October 7, 1994)
  • K935254 — DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA (September 19, 1994)

FDA data resources