FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MULTISTAT III URIC ACID TEST
K Number: K771509
·
Decision Sep 13, 1977
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
30
Applicant Total
321
Review Days
39
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Basic Information
- Device Name
- MULTISTAT III URIC ACID TEST
- K Number
- K771509
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Instrumentation Laboratory CO
- Date Received
- August 5, 1977
- Decision Date
- September 13, 1977
- Product Code
- CDO
- 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 |
|---|---|---|---|
| CDO | Acid, Uric, Uricase (U.V.) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDO), ordered by most recent decision date.
RANDOX URIC ACID
FDA 510(k)
FDA Class 1
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SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT
FDA 510(k)
FDA Class 1
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URIC ACID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URIC ACID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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