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510(k) K962674

STA - VWF CONTROL [N]+[P] KIT by American Bioproducts Co. — Product Code GGN

K962674 is an FDA 510(k) premarket notification submitted by American Bioproducts Co. for the device "STA - VWF CONTROL [N]+[P] KIT". The FDA issued a decision of Substantially Equivalent on July 23, 1996. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. American Bioproducts Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1996
Date Received
July 9, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Control
Device Class
Class II
Regulation Number
864.5425
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)
  • 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)
  • 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 GGN

  • K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (June 21, 2017)
  • K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit (March 16, 2017)
  • K161316 — George King Coumadin Plasma (February 23, 2017)
  • K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (January 5, 2017)
  • K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (June 3, 2016)
  • K150144 — VisuCon-F Low Fibrinogen Control Plasma (March 6, 2016)
  • K142132 — POOL NORM (December 12, 2014)
  • K133582 — HEMOSIL D-DIMER HS 500 CONTROL (August 15, 2014)
  • K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DI (July 3, 2013)
  • K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 (May 31, 2013)

FDA data resources