Home / 510(k) Clearances / K971519

510(k) K971519

ASSERACHROM TPA TEST KIT by American Bioproducts Co. — Product Code GGP

K971519 is an FDA 510(k) premarket notification submitted by American Bioproducts Co. for the device "ASSERACHROM TPA TEST KIT". The FDA issued a decision of Substantially Equivalent on August 19, 1997. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. American Bioproducts Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1997
Date Received
April 25, 1997
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 Bioproducts Co.

  • K983460 — STAR AUTOMATED MULTI-PARAMETRIC ANALYZER (November 12, 1998)
  • K964716 — STA LIATEST CONTROL [N]+[P] KIT (June 26, 1997)
  • K964728 — STA-LIATEST D-DI TEST KIT (June 26, 1997)
  • K964718 — STA D-DI CALIBRATOR KIT (May 23, 1997)
  • K962675 — STA - LIATEST VWF TEST KIT (October 25, 1996)
  • K962671 — STA-VWF CALIBRATOR KIT (September 13, 1996)
  • K962674 — STA - VWF CONTROL [N]+[P] KIT (July 23, 1996)
  • K961579 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (July 10, 1996)
  • K955040 — AT-III CONTROL PLASMA KIT (January 31, 1996)
  • K954040 — ASSERACHROM TOTAL PROTEIN S KIT (November 13, 1995)

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