FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UREA
K Number: K850937
·
Decision Jun 10, 1985
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
20
Applicant Total
11
Review Days
95
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Basic Information
- Device Name
- UREA
- K Number
- K850937
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dilab, Inc.
- Date Received
- March 7, 1985
- Decision Date
- June 10, 1985
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDW), ordered by most recent decision date.
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FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814
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AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346
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UREA NITROGEN REAGENT SET
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UREA NITROGEN REAGENT SET
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Other Clearances by Dilab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862530 | RAPID AS LATEX | Apr 21, 1987 | Substantially Equivalent |
| K850931 | ALBUMIN | Jun 26, 1985 | Substantially Equivalent |
| K850938 | CHOLESTEROL | Jun 25, 1985 | Substantially Equivalent |
| K850936 | TOTAL PROTEINS | Jun 25, 1985 | Substantially Equivalent |
| K850932 | CREATININE | Jun 25, 1985 | Substantially Equivalent |
| K850933 | URIC ACID | Jun 25, 1985 | Substantially Equivalent |
| K850934 | PHOSPHORUS | Jun 25, 1985 | Substantially Equivalent |
| K850935 | CHLORIDE | Jun 10, 1985 | Substantially Equivalent |
| K850930 | GLUCOSE | Jun 10, 1985 | Substantially Equivalent |
| K850929 | CALCIUM | Jun 10, 1985 | Substantially Equivalent |