FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOOD UREA NITROGEN (BUN) TESTCARD
K Number: K860543
·
Decision Apr 21, 1986
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
14
Applicant Total
3
Review Days
67
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Basic Information
- Device Name
- BLOOD UREA NITROGEN (BUN) TESTCARD
- K Number
- K860543
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ilex Corp.
- Date Received
- February 13, 1986
- Decision Date
- April 21, 1986
- Product Code
- CDS
- 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 |
|---|---|---|---|
| CDS | Electrode, Ion Specific, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
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epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
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