FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URINARY VMA - SCREEN TEST KIT
K Number: K772151
·
Decision Nov 30, 1977
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
11
Applicant Total
4
Review Days
15
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Basic Information
- Device Name
- URINARY VMA - SCREEN TEST KIT
- K Number
- K772151
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1795
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Eppendorf-Brinkmann, Inc.
- Date Received
- November 15, 1977
- Decision Date
- November 30, 1977
- Product Code
- CDF
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | FDA class 1 | Clinical Chemistry |
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