FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GTI-FVIII INHIBITOR ASSAY
K Number: K993553
·
Decision Feb 1, 2000
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
6
Review Days
104
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Basic Information
- Device Name
- GTI-FVIII INHIBITOR ASSAY
- K Number
- K993553
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genetic Testing Institute
- Date Received
- October 20, 1999
- Decision Date
- February 1, 2000
- Product Code
- GGP
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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Other Clearances by Genetic Testing Institute
| K Number | Device Name | ||
|---|---|---|---|
| K082205 | FACTOR VIII ANTIBODY SCREEN | Nov 20, 2008 | Substantially Equivalent |
| K071781 | PF4 IGG | Dec 19, 2007 | Substantially Equivalent |
| K053559 | PF4 ENHANCED SOLID PHASE ELISA | Jan 20, 2006 | Substantially Equivalent |
| K983379 | GTI-PF4 ELISA | Mar 9, 1999 | Substantially Equivalent |
| K841114 | ALLO-TYPE HUMAN IMMUNOGLOBULIN- | Jun 14, 1984 | Substantially Equivalent |