BIOTIS HAEMOPHILUS IDENTIFICATION QUAD— 510(k) K862387
Substantially EquivalentOtisville Biotech, Inc.
FDA 510(k) clearance K862387 for BIOTIS HAEMOPHILUS IDENTIFICATION QUAD, Substantially Equivalent on 1986-07-03. Applicant: Otisville Biotech, Inc.. Device class: 1.
Clearance details
- Applicant
- Otisville Biotech, Inc.
- Product code
- Code JSH
- Device class
- Class 1
- Regulation
- 21 CFR 866.2320
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Otisville, NY, US
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