FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UREA NITROGEN (BUN) LIQUI-UV
K Number: K962418
·
Decision Dec 26, 1996
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
116
Applicant Total
47
Review Days
185
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Basic Information
- Device Name
- UREA NITROGEN (BUN) LIQUI-UV
- K Number
- K962418
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stanbio Laboratory
- Date Received
- June 24, 1996
- Decision Date
- December 26, 1996
- Product Code
- CDQ
- 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 |
|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
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