FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALLO-TYPE HUMAN IMMUNOGLOBULIN-
K Number: K841114
·
Decision Jun 14, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
6
Review Days
91
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Basic Information
- Device Name
- ALLO-TYPE HUMAN IMMUNOGLOBULIN-
- K Number
- K841114
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5065
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Genetic Testing Institute
- Date Received
- March 15, 1984
- Decision Date
- June 14, 1984
- Product Code
- DGX
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DGX | Ng1m(A), Antigen, Antiserum, Control | FDA class 1 | Immunology |
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 |
| K993553 | GTI-FVIII INHIBITOR ASSAY | Feb 1, 2000 | Substantially Equivalent |
| K983379 | GTI-PF4 ELISA | Mar 9, 1999 | Substantially Equivalent |