BD MAX CT/GC/TV 20-Day QC Panel— 510(k) K181683
Substantially EquivalentMicrobiologics, Inc.
FDA 510(k) clearance K181683 for BD MAX CT/GC/TV 20-Day QC Panel, Substantially Equivalent on 2018-08-28. Applicant: Microbiologics, Inc.. Device class: 2.
Clearance details
- Applicant
- Microbiologics, Inc.
- Product code
- Code PMN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3920
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Cloud, MN, US
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