IMMPULSE TOBRAMYCIN ASSAY REAGENTS— 510(k) K840847
Substantially EquivalentParagon Diagnostics, Inc.
FDA 510(k) clearance K840847 for IMMPULSE TOBRAMYCIN ASSAY REAGENTS, Substantially Equivalent on 1984-04-04. Applicant: Paragon Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Paragon Diagnostics, Inc.
- Product code
- Code LCR
- Device class
- Class 2
- Regulation
- 21 CFR 862.3900
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code LCR
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