FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTRE/ZYME IGE KIT
K Number: K831485
·
Decision Jun 2, 1983
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
82
Review Days
24
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Basic Information
- Device Name
- VENTRE/ZYME IGE KIT
- K Number
- K831485
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Ventrex Laboratories, Inc.
- Date Received
- May 9, 1983
- Decision Date
- June 2, 1983
- Product Code
- DGC
- 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 |
|---|---|---|---|
| DGC | Ige, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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Other Clearances by Ventrex Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914554 | SPECIFIC IGE EIA-TURBO ASSAY | Mar 13, 1992 | Substantially Equivalent |
| K913833 | VENTREX ALLERGEN DISC | Feb 21, 1992 | Substantially Equivalent |
| K913434 | VENTREX COATED TUBE INTACT PTH | Oct 25, 1991 | Substantially Equivalent |
| K905612 | VENTREX COATED TUBE IGE RADIOIMMUNOASSAY | Feb 21, 1991 | Substantially Equivalent |
| K905636 | VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY | Feb 7, 1991 | Substantially Equivalent |
| K905247 | SHBG IRMA KIT | Jan 17, 1991 | Substantially Equivalent |
| K904330 | TURBO-RAST SPECIFIC IGE ASSAY | Dec 7, 1990 | Substantially Equivalent |
| K903000 | TURBO-RAST SPECIFIC IGE ASSAY | Jul 31, 1990 | Substantially Equivalent |
| K897083 | VENTRESIGN STREP A TEST | Jan 22, 1990 | Substantially Equivalent |
| K895648 | COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN. | Jan 18, 1990 | Substantially Equivalent |