SYSTEM U3 FOR GENTAMICIN— 510(k) K983252
Substantially EquivalentAb Biodisk North America, Inc.
FDA 510(k) clearance K983252 for SYSTEM U3 FOR GENTAMICIN, Substantially Equivalent on 1998-11-20. 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
- Piscataway, NJ, US
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More clearances from Ab Biodisk North America, Inc.
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