OPUS B12— 510(k) K953455
Substantially EquivalentBehring Diagnostics, Inc.
FDA 510(k) clearance K953455 for OPUS B12, Substantially Equivalent on 1995-08-23. Applicant: Behring Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Behring Diagnostics, Inc.
- Product code
- Code CDD
- Device class
- Class 2
- Regulation
- 21 CFR 862.1810
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westwood, MA, US
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More clearances from Behring Diagnostics, Inc.
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