FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTRESCREEN (TM) MONO
K Number: K872032
·
Decision Jun 29, 1987
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
58
Applicant Total
82
Review Days
33
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Basic Information
- Device Name
- VENTRESCREEN (TM) MONO
- K Number
- K872032
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Ventrex Laboratories, Inc.
- Date Received
- May 27, 1987
- Decision Date
- June 29, 1987
- Product Code
- KTN
- 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 |
|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTN), ordered by most recent decision date.
OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
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DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
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CLEARVIEW IM
FDA 510(k)
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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 |