FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UREA NITROGEN (BUN)
K Number: K880078
·
Decision Feb 11, 1988
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
116
Applicant Total
20
Review Days
31
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Basic Information
- Device Name
- UREA NITROGEN (BUN)
- K Number
- K880078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Tech-Neal Scientific, Inc.
- Date Received
- January 11, 1988
- Decision Date
- February 11, 1988
- 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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Other Clearances by Tech-Neal Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882256 | MAGNESIUM REAGENT SET | Aug 8, 1988 | Substantially Equivalent |
| K882459 | DIAZO, COLORIMETRIC BILIRUBIN | Aug 2, 1988 | Substantially Equivalent |
| K881239 | GAMMA GLUTAMYL TRANSFERASE REAGENT SET | May 31, 1988 | Substantially Equivalent |
| K881241 | TOTAL BILIRUBIN REAGENT | May 27, 1988 | Substantially Equivalent |
| K880237 | CHOLESTEROL | Apr 28, 1988 | Substantially Equivalent |
| K881237 | CREATINE KINASE (CK) REAGENT SET | Apr 28, 1988 | Substantially Equivalent |
| K881240 | CHLORIDE REAGENT SET | Apr 28, 1988 | Substantially Equivalent |
| K880277 | URIC ACID REAGENT SET | Apr 18, 1988 | Substantially Equivalent |
| K880845 | CALCIUM REAGENT SET | Apr 5, 1988 | Substantially Equivalent |
| K880842 | LDH-L REAGENT SET | Apr 5, 1988 | Substantially Equivalent |