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510(k) K943519

HBPM/LMWH CONTROL KIT by American Bioproducts Co. — Product Code KFF

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
September 26, 1995
Date Received
July 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Heparin
Device Class
Class II
Regulation Number
864.7525
Review Panel
HE
Submission Type

Other clearances by American Bioproducts Co.

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  • 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)
  • 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)

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  • K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS (June 2, 2009)
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  • K010455 — ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN (June 7, 2001)
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