Acuitas AMR Gene Panel— 510(k) K191288
Substantially EquivalentOpgen, Inc.
FDA 510(k) clearance K191288 for Acuitas AMR Gene Panel, Substantially Equivalent on 2021-09-30. Applicant: Opgen, Inc.. Device class: 2.
Clearance details
- Applicant
- Opgen, Inc.
- Product code
- Code PMY
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Recent devices under product code PMY
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