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510(k) K063323

SPECTROLYSE PAI-1, MODEL 101201 by American Diagnostica, Inc. — Product Code GGP

K063323 is an FDA 510(k) premarket notification submitted by American Diagnostica, Inc. for the device "SPECTROLYSE PAI-1, MODEL 101201". The FDA issued a decision of Substantially Equivalent on August 15, 2007. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. American Diagnostica, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2007
Date Received
November 3, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Qualitative And Quantitative Factor Deficiency
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type

Other clearances by American Diagnostica, Inc.

  • K080069 — DIMERTEST (February 13, 2008)
  • 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)
  • K935254 — DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA (September 19, 1994)

Other clearances for product code GGP

  • K251440 — CRYOcheck Chromogenic Factor VIII (August 25, 2025)
  • K230852 — HemosIL Chromogenic Factor IX (December 13, 2023)
  • K220728 — vWF Ag (June 2, 2023)
  • K214002 — CRYOcheck Chromogenic Factor IX (December 23, 2022)
  • K223402 — HemosIL von Willebrand Factor Antigen (December 9, 2022)
  • K200033 — HemosIL von Willebrand Factor Antigen (August 19, 2020)
  • K193204 — Cryocheck Chromogenic Factor VIII (July 17, 2020)
  • K183440 — CRYOcheck FVIII Inhibitor Kit (March 12, 2019)
  • K181525 — INNOVANCE Free PS Ag (September 7, 2018)
  • K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (March 13, 2014)

FDA data resources