IMMPULSE TBC ASSAY REAGENTS— 510(k) K840853
Substantially EquivalentParagon Diagnostics, Inc.
FDA 510(k) clearance K840853 for IMMPULSE TBC ASSAY REAGENTS, Substantially Equivalent on 1984-04-01. Applicant: Paragon Diagnostics, Inc..
Clearance details
- Applicant
- Paragon Diagnostics, Inc.
- Product code
- Code KHQ
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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