LIAT STREP A ASSAY— 510(k) K141338
Substantially EquivalentIquum, Inc.
FDA 510(k) clearance K141338 for LIAT STREP A ASSAY, Substantially Equivalent on 2014-11-04. Applicant: Iquum, Inc.. Device class: 2.
Clearance details
- Applicant
- Iquum, Inc.
- Product code
- Code PGX
- Device class
- Class 2
- Regulation
- 21 CFR 866.2680
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
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