ACE(TM) CEDIA(R) PHENYTOIN ASSAY— 510(k) K944085
Substantially EquivalentSchiapparelli Biosystems, Inc.
FDA 510(k) clearance K944085 for ACE(TM) CEDIA(R) PHENYTOIN ASSAY, Substantially Equivalent on 1994-12-28. Applicant: Schiapparelli Biosystems, Inc.. Device class: 2.
Clearance details
- Applicant
- Schiapparelli Biosystems, Inc.
- Product code
- Code DIP
- Device class
- Class 2
- Regulation
- 21 CFR 862.3350
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
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More clearances from Schiapparelli Biosystems, Inc.
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