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510(k) K012386

ACTICLOT PROTEIN S, MODEL 843L by American Diagnostica, Inc. — Product Code GGP

K012386 is an FDA 510(k) premarket notification submitted by American Diagnostica, Inc. for the device "ACTICLOT PROTEIN S, MODEL 843L". The FDA issued a decision of Substantially Equivalent on September 14, 2001. 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
September 14, 2001
Date Received
July 27, 2001
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)
  • 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)
  • 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