ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL— 510(k) K933885
Substantially EquivalentAlamar Biosciences, Inc.
FDA 510(k) clearance K933885 for ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL, Substantially Equivalent on 1993-11-16. Applicant: Alamar Biosciences, Inc.. Device class: 2.
Clearance details
- Applicant
- Alamar Biosciences, Inc.
- Product code
- Code JWY
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sacramento, CA, US
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More clearances from Alamar Biosciences, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.