MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT— 510(k) K880665
Substantially EquivalentAllelix Diagnostics, Inc.
FDA 510(k) clearance K880665 for MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT, Substantially Equivalent on 1988-03-01. Applicant: Allelix Diagnostics, Inc..
Clearance details
- Applicant
- Allelix Diagnostics, Inc.
- Product code
- Code GTZ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Canada L4v 1p1, CA
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