FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STANBIO DIRECT URIC ACID TEST SET #0770
K Number: K800190
·
Decision Feb 13, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
14
Applicant Total
47
Review Days
15
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Basic Information
- Device Name
- STANBIO DIRECT URIC ACID TEST SET #0770
- K Number
- K800190
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Stanbio Laboratory
- Date Received
- January 29, 1980
- Decision Date
- February 13, 1980
- 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
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URIC ACID REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URIC ACID REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PHOSPHOTUNGSTATE REDUCTION, URIC ACID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URIC ACID (TPTZ) COLORINMETRIC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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