ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT— 510(k) K080739
Substantially EquivalentAbbott Molecular, Inc.
FDA 510(k) clearance K080739 for ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT, Substantially Equivalent on 2008-07-10. Applicant: Abbott Molecular, Inc.. Device class: 1.
Clearance details
- Applicant
- Abbott Molecular, Inc.
- Product code
- Code MKZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3120
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Des Plaines, IL, US
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