ETEST FOR AMPICILLIN/SULBACTAM 2/1— 510(k) K935519
Substantially EquivalentAb Biodisk North America, Inc.
FDA 510(k) clearance K935519 for ETEST FOR AMPICILLIN/SULBACTAM 2/1, Substantially Equivalent on 1994-11-04. Applicant: Ab Biodisk North America, Inc.. Device class: 2.
Clearance details
- Applicant
- Ab Biodisk North America, 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
- S-17136 Solna, Sweden, SE
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More clearances from Ab Biodisk North America, Inc.
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