BIOGRAM— 510(k) K854521
Substantially EquivalentGiles Scientific, Inc.
FDA 510(k) clearance K854521 for BIOGRAM, Substantially Equivalent on 1985-12-23. Applicant: Giles Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Giles Scientific, Inc.
- Product code
- Code JTZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.1700
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
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