FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTANA RED DETECTION KIT
K Number: K932386
·
Decision Aug 9, 1993
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
41
Review Days
84
Basic Information
- Device Name
- VENTANA RED DETECTION KIT
- K Number
- K932386
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VENTANA MEDICAL SYSTEMS, INC.
- Date Received
- May 17, 1993
- Decision Date
- August 9, 1993
- Product Code
- DEY
- 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 |
|---|---|---|---|
| DEY | Igm, Peroxidase, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
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