SERALYZER ARIS PHENYTOIN REAGENT STRIPS— 510(k) K842092
Substantially EquivalentMiles Laboratories, Inc.
FDA 510(k) clearance K842092 for SERALYZER ARIS PHENYTOIN REAGENT STRIPS, Substantially Equivalent on 1985-03-19. Applicant: Miles Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Miles Laboratories, 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
- Elkhart, IN, US
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More clearances from Miles Laboratories, Inc.
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