FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UREA NITROGEN TEST
K Number: K781899
·
Decision Dec 20, 1978
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
15
Applicant Total
4
Review Days
37
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Basic Information
- Device Name
- UREA NITROGEN TEST
- K Number
- K781899
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Wako Intl., Inc.
- Date Received
- November 13, 1978
- Decision Date
- December 20, 1978
- Product Code
- CDL
- 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 |
|---|---|---|---|
| CDL | Berthelot Indophenol, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
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