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510(k) K935254

DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA by American Diagnostica, Inc. — Product Code GIZ

K935254 is an FDA 510(k) premarket notification submitted by American Diagnostica, Inc. for the device "DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA". The FDA issued a decision of Substantially Equivalent on September 19, 1994. The device falls under product code GIZ (Plasma, Control, Normal), a Class II device regulated under 21 CFR 864.5425. American Diagnostica, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1994
Date Received
November 1, 1993
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 American Diagnostica, Inc.

  • K080069 — DIMERTEST (February 13, 2008)
  • K063323 — SPECTROLYSE PAI-1, MODEL 101201 (August 15, 2007)
  • K052124 — ACTICLOT, MODEL 824 (October 17, 2005)
  • K013637 — ACTICHROME HEPARIN (ANTI-FIIA) (April 16, 2002)
  • K013492 — IMUBIND TPA ELISA, MODEL 860 (March 13, 2002)
  • K013318 — ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 (March 8, 2002)
  • K013168 — IMUBIND PLASMA PAI-1 ELISA,MODEL 822 (March 7, 2002)
  • K012386 — ACTICLOT PROTEIN S, MODEL 843L (September 14, 2001)
  • K940490 — DV TEST AND DVV CONFIRM (April 5, 1995)

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)
  • K984129 — COAGULATION CONTROL LEVEL 1 (NORMAL) (December 1, 1998)
  • 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)

FDA data resources