Factor Deficient Plasmas - Factor Xi (11)
FDA 510(k) K972286 · Universal Reagents, Inc.
510(k) numberK972286
Submission
- Device name
- Factor Deficient Plasmas - Factor Xi (11)
- Applicant
- Universal Reagents, Inc.
Indianapolis, IN, US - Received
- June 19, 1997
- Decision date
- July 14, 1997
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K973143 | Universal Reagent Factor Xii (Twelve) Deficient PlasmaGGP · Traditional | 09/25/1997SE |
| K972288 | Factor Deficient Plasmas - Factor Ix (9)GGP · Traditional | 07/14/1997SE |
| K970607 | Universal Reagent Factor Vii Deficient PlasmaGJT · Traditional | 04/25/1997SE |
| K970593 | Universal Reagent Factor Viii Deficient PlasmaGJT · Traditional | 04/25/1997SE |
| K964459 | Universal Reagent Factor X Deficient PlasmaGGP · Traditional | 12/18/1996SE |
| K964270 | Universal Reagent Factor V Deficient PlasmaGGP · Traditional | 12/18/1996SE |
| K961929 | Factor Deficient PlasmaGGP · Traditional | 10/10/1996SE |
Questions and answers
When was Factor Deficient Plasmas - Factor Xi (11) cleared by the FDA?
Factor Deficient Plasmas - Factor Xi (11) (K972286) received a 510(k) decision of Substantially Equivalent on July 14, 1997, 25 days after the submission was received.
What is the product code of K972286?
The FDA product code is GJT – Plasma, Coagulation Factor Deficient, a Class II (moderate risk) device regulated under 21 CFR 864.7290.