FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BUN TEST UNI-UV BLOOD UREA NITROGEN TEST
K Number: K780943
·
Decision Jul 27, 1978
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
116
Applicant Total
82
Review Days
50
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Basic Information
- Device Name
- BUN TEST UNI-UV BLOOD UREA NITROGEN TEST
- K Number
- K780943
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sclavo, Inc.
- Date Received
- June 7, 1978
- Decision Date
- July 27, 1978
- Product Code
- CDQ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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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|---|---|---|---|
| K914789 | ELISA CMV IGM | Mar 4, 1992 | Substantially Equivalent |
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| K895943 | NORMAL AND ABNORMAL CONTROL SERA | Dec 27, 1989 | Substantially Equivalent |
| K895822 | TOTAL BILIRUBIN L.F. | Nov 14, 1989 | Substantially Equivalent |
| K895847 | CREATININE 340 (ENZYMATIC) | Oct 30, 1989 | Substantially Equivalent |
| K880049 | CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE | Jan 27, 1989 | Substantially Equivalent |
| K880199 | CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE | Jan 27, 1989 | Substantially Equivalent |
| K873496 | ATYPICAL CHOLINESTERASE | Jan 27, 1989 | Substantially Equivalent |
| K884035 | SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER | Dec 29, 1988 | Substantially Equivalent |