EMIT II PLUS METHADONE ASSAY, MODEL OSRE229— 510(k) K010962
Substantially EquivalentSyva Co., Dade Behring, Inc.
FDA 510(k) clearance K010962 for EMIT II PLUS METHADONE ASSAY, MODEL OSRE229, Substantially Equivalent on 2001-04-26. Applicant: Syva Co., Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Syva Co., Dade Behring, Inc.
- Product code
- Code DJR
- Device class
- Class 2
- Regulation
- 21 CFR 862.3620
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
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More clearances from Syva Co., Dade Behring, Inc.
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