SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM— 510(k) K020794
Substantially EquivalentBayer Diagnostics Corp.
FDA 510(k) clearance K020794 for SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM, Substantially Equivalent on 2002-07-11. Applicant: Bayer Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Diagnostics Corp.
- Product code
- Code DKJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3830
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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More clearances from Bayer Diagnostics Corp.
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