Factor Vii Deficient Plasma
FDA 510(k) K900407 · Sigma Chemical Co.
510(k) numberK900407
Submission
- Device name
- Factor Vii Deficient Plasma
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- January 29, 1990
- Decision date
- March 6, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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Questions and answers
When was Factor Vii Deficient Plasma cleared by the FDA?
Factor Vii Deficient Plasma (K900407) received a 510(k) decision of Substantially Equivalent on March 6, 1990, 36 days after the submission was received.
What is the product code of K900407?
The FDA product code is GJT – Plasma, Coagulation Factor Deficient, a Class II (moderate risk) device regulated under 21 CFR 864.7290.