OPUS TDM CONTROLS— 510(k) K954291
Substantially EquivalentBehring Diagnostics, Inc.
FDA 510(k) clearance K954291 for OPUS TDM CONTROLS, Substantially Equivalent on 1995-11-20. Applicant: Behring Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Behring Diagnostics, Inc.
- Product code
- Code DIF
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westwood, MA, US
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