BIOTIS ABNORMAL CLINICAL CHEM SERUM-— 510(k) K840458
Substantially EquivalentOtisville Biotech, Inc.
FDA 510(k) clearance K840458 for BIOTIS ABNORMAL CLINICAL CHEM SERUM-, Substantially Equivalent on 1984-04-17. Applicant: Otisville Biotech, Inc.. Device class: 1.
Clearance details
- Applicant
- Otisville Biotech, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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