FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELVI URIC ACID-COLORIMETRIC METHOD
K Number: K792403
·
Decision Dec 7, 1979
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
14
Applicant Total
66
Review Days
11
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Basic Information
- Device Name
- ELVI URIC ACID-COLORIMETRIC METHOD
- K Number
- K792403
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Volu Sol Medical Industries
- Date Received
- November 26, 1979
- Decision Date
- December 7, 1979
- 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
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URIC ACID
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PHOSPHOTUNGSTATE REDUCTION, URIC ACID
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SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
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Other Clearances by Volu Sol Medical Industries
| K Number | Device Name | ||
|---|---|---|---|
| K822126 | VOLU-SOL CARNOY FLUID | Aug 5, 1982 | Substantially Equivalent |
| K822128 | VOLU-SOL SINGLE DIFFERENTIAL STAIN | Aug 5, 1982 | Substantially Equivalent |
| K822127 | VOLU-SOL ZENKERS FIXATIVE | Aug 5, 1982 | Substantially Equivalent |
| K822129 | VOLU-SOL BOVINS FIXATIVE | Aug 5, 1982 | Substantially Equivalent |
| K822036 | VOLU-SOL DECALCIFER | Aug 3, 1982 | Substantially Equivalent |
| K822035 | VOLU-SOL GILLS EA | Aug 3, 1982 | Substantially Equivalent |
| K822038 | VOLU-SOL ORANGE G-6(GILLS-MOD | Aug 3, 1982 | Substantially Equivalent |
| K822037 | VOLU-SOL TAP WATER SUBSTITUTE | Aug 3, 1982 | Substantially Equivalent |
| K812906 | ELVI BICLOT 816 | Jul 22, 1982 | Substantially Equivalent |
| K821541 | HEMATOXYLIN III | Jun 10, 1982 | Substantially Equivalent |