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510(k) K964718

STA D-DI CALIBRATOR KIT by American Bioproducts Co. — Product Code DAP

K964718 is an FDA 510(k) premarket notification submitted by American Bioproducts Co. for the device "STA D-DI CALIBRATOR KIT". The FDA issued a decision of Substantially Equivalent on May 23, 1997. The device falls under product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 864.7320. American Bioproducts Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1997
Date Received
November 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

Other clearances by American Bioproducts Co.

  • K983460 — STAR AUTOMATED MULTI-PARAMETRIC ANALYZER (November 12, 1998)
  • K971519 — ASSERACHROM TPA TEST KIT (August 19, 1997)
  • K964716 — STA LIATEST CONTROL [N]+[P] KIT (June 26, 1997)
  • K964728 — STA-LIATEST D-DI TEST KIT (June 26, 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 DAP

  • K172903 — HemosIL D-Dimer HS 500 (November 22, 2017)
  • K162227 — STA® - Liatest® D-Di (December 10, 2016)
  • K160885 — HemosIL D-Dimer HS (October 27, 2016)
  • K151534 — HemosIL D-Dimer HS (July 6, 2015)
  • K141144 — STA LIATEST D-DI (September 3, 2014)
  • K112818 — VIDAS D-DIMER EXCLUSION II (DEX2) (July 31, 2012)
  • K110303 — STRATUS CS ACUTE CARE D-DIMER (May 16, 2011)
  • K093626 — INNOVANCE D-DIMER, MODEL OPBP09 (November 29, 2010)
  • K090264 — HEMOSIL D-DIMER HS 500, CONTROLS (February 5, 2010)
  • K091916 — INNOVANCE D-DIMER, MODEL OPBP09 (October 29, 2009)

FDA data resources