STANBIO DIRECT URIC ACID TEST SET #0770— 510(k) K800190
Substantially EquivalentStanbio Laboratory
FDA 510(k) clearance K800190 for STANBIO DIRECT URIC ACID TEST SET #0770, Substantially Equivalent on 1980-02-13. Applicant: Stanbio Laboratory. Device class: 1.
Clearance details
- Applicant
- Stanbio Laboratory
- Product code
- Code CDH
- Device class
- Class 1
- Regulation
- 21 CFR 862.1775
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.