BIOGRAM— 510(k) K843725
Substantially EquivalentGiles Scientific, Inc.
FDA 510(k) clearance K843725 for BIOGRAM, Substantially Equivalent on 1985-05-21. Applicant: Giles Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Giles Scientific, Inc.
- Product code
- Code JTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1620
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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