EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229— 510(k) K010934
Substantially EquivalentSyva Co., Dade Behring, Inc.
FDA 510(k) clearance K010934 for EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229, Substantially Equivalent on 2001-04-20. Applicant: Syva Co., Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Syva Co., Dade Behring, Inc.
- Product code
- Code DIS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
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