FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URIC ACID
K Number: K850933
·
Decision Jun 25, 1985
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
14
Applicant Total
11
Review Days
110
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Basic Information
- Device Name
- URIC ACID
- K Number
- K850933
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dilab, Inc.
- Date Received
- March 7, 1985
- Decision Date
- June 25, 1985
- Product Code
- CDH
- 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 |
|---|---|---|---|
| CDH | Acid, Uric, Phosphotungstate Reduction | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDH), ordered by most recent decision date.
URIC ACID REAGENT SET
FDA 510(k)
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URIC ACID REAGENT SET
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PHOSPHOTUNGSTATE REDUCTION, URIC ACID
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URIC ACID (TPTZ) COLORINMETRIC
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SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
FDA 510(k)
FDA Class 1
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STANBIO DIRECT URIC ACID TEST SET #0770
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 |
| K850934 | PHOSPHORUS | Jun 25, 1985 | Substantially Equivalent |
| K850935 | CHLORIDE | Jun 10, 1985 | Substantially Equivalent |
| K850937 | UREA | Jun 10, 1985 | Substantially Equivalent |
| K850930 | GLUCOSE | Jun 10, 1985 | Substantially Equivalent |
| K850929 | CALCIUM | Jun 10, 1985 | Substantially Equivalent |