FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DAB DETECTION KIT
K Number: K920600
·
Decision May 11, 1992
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
48
Review Days
90
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Basic Information
- Device Name
- DAB DETECTION KIT
- K Number
- K920600
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ventana Medical Systems, Inc.
- Date Received
- February 11, 1992
- Decision Date
- May 11, 1992
- 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
Other 510(k) clearances with the same product code (DEY), ordered by most recent decision date.
VENTANA RED DETECTION KIT
FDA 510(k)
FDA Class 2
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AEC DETECTION KIT
FDA 510(k)
FDA Class 2
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