FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UREA NITROGEN
K Number: K781305
·
Decision Aug 31, 1978
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
20
Applicant Total
12
Review Days
34
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Basic Information
- Device Name
- UREA NITROGEN
- K Number
- K781305
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Analytical & Research Chemicals, Inc.
- Date Received
- July 28, 1978
- Decision Date
- August 31, 1978
- Product Code
- CDW
- 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 |
|---|---|---|---|
| CDW | Diacetyl-Monoxime, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
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Other Clearances by Analytical & Research Chemicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823806 | DIRECT CREATININE PROCEDURE | Jan 14, 1983 | Substantially Equivalent |
| K823786 | ALKALINE PHOSPHATASE | Jan 14, 1983 | Substantially Equivalent |
| K823784 | ENZYMATIC CHOLESTEROL (COLORIMETRIC | Jan 14, 1983 | Substantially Equivalent |
| K781441 | BCG ALBUMIN REAGET | Oct 10, 1978 | Substantially Equivalent |
| K781460 | CHLORIDE REAGENT | Oct 10, 1978 | Substantially Equivalent |
| K781307 | GLUCOSE DETERM. KIT | Aug 31, 1978 | Substantially Equivalent |
| K781309 | GOT PROCEDURE | Aug 31, 1978 | Substantially Equivalent |
| K781323 | LDH PROCEDURE | Aug 31, 1978 | Substantially Equivalent |
| K781306 | UREA NITROGEN TEST KIT | Aug 31, 1978 | Substantially Equivalent |
| K781308 | GLUCOLOUR | Aug 31, 1978 | Substantially Equivalent |