IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS— 510(k) K865000
Substantially EquivalentSclavo, Inc.
FDA 510(k) clearance K865000 for IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS, Substantially Equivalent on 1987-02-06. Applicant: Sclavo, Inc.. Device class: 2.
Clearance details
- Applicant
- Sclavo, Inc.
- Product code
- Code LET
- Device class
- Class 2
- Regulation
- 21 CFR 862.3660
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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