Sta-Vwf Calibrator Kit
FDA 510(k) K962671 · American Bioproducts Co.
510(k) numberK962671
Submission
- Device name
- Sta-Vwf Calibrator Kit
- Applicant
- American Bioproducts Co.
Parisppany, NJ, US - Received
- July 9, 1996
- Decision date
- September 13, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GJT – Plasma, Coagulation Factor Deficient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
Other 510(k)s with product code GJT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWFGJT · Traditional | Precision Biologic, Inc. | 09/13/2023SE |
| K180486 | HemosIL Factor XII Deficient PlasmaGJT · Special | Instrumentation Laboratory CO | 03/22/2018SE |
| K102908 | Nofact IxGJT · Traditional | R2 Diagnostics, Inc. | 12/19/2011SE |
| K102851 | Nofact ViiiGJT · Traditional | R2 Diagnostics, Inc. | 12/19/2011SE |
| K110237 | Hemosil Factor Viii Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 07/08/2011SE |
| K050661 | Hemosil Factor II Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 05/02/2005SE |
| K043459 | Hemosil Factor Xii Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 02/09/2005SE |
| K040362 | Diapharma Factor X KitGJT · Traditional | Diapharma Group, Inc. | 07/12/2004SE |
| K034007 | Hemosil Factor Viii Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 02/13/2004SE |
| K031829 | Hemosil Factor Ix Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 07/31/2003SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K983460 | Star Automated Multi-Parametric AnalyzerJPA · Traditional | 11/12/1998SE |
| K971519 | Asserachrom Tpa Test KitGGP · Traditional | 08/19/1997SE |
| K964728 | Sta-Liatest D-Di Test KitDAP · Traditional | 06/26/1997SE |
| K964716 | Sta Liatest Control [N]+[P] KitGGN · Traditional | 06/26/1997SE |
| K964718 | Sta D-Di Calibrator KitDAP · Traditional | 05/23/1997SE |
| K962675 | Sta - Liatest VWF Test KitGJT · Traditional | 10/25/1996SE |
| K962674 | Sta - VWF Control [N]+[P] KitGGN · Traditional | 07/23/1996SE |
| K961579 | Sta Compact Automated Multi-Parametric AnalyzerGKP · Traditional | 07/10/1996SE |
| K955040 | At-Iii Control Plasma KitGGC · Traditional | 01/31/1996SE |
| K954040 | Asserachrom Total Protein S KitGGP · Traditional | 11/13/1995SE |
Questions and answers
When was Sta-Vwf Calibrator Kit cleared by the FDA?
Sta-Vwf Calibrator Kit (K962671) received a 510(k) decision of Substantially Equivalent on September 13, 1996, 66 days after the submission was received.
What is the product code of K962671?
The FDA product code is GJT – Plasma, Coagulation Factor Deficient, a Class II (moderate risk) device regulated under 21 CFR 864.7290.