T/K (ATA/AMA) UNIVERSAL BIOPAK— 510(k) K802308
Substantially EquivalentBioware Products
FDA 510(k) clearance K802308 for T/K (ATA/AMA) UNIVERSAL BIOPAK, Substantially Equivalent on 1980-12-01. Applicant: Bioware Products. Device class: 2.
Clearance details
- Applicant
- Bioware Products
- Product code
- Code DBM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5090
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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More clearances from Bioware Products
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