IMMPULSE T4 ASSAY REAGENTS— 510(k) K840852
Substantially EquivalentParagon Diagnostics, Inc.
FDA 510(k) clearance K840852 for IMMPULSE T4 ASSAY REAGENTS, Substantially Equivalent on 1984-04-18. Applicant: Paragon Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Paragon Diagnostics, Inc.
- Product code
- Code CDX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1700
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CDX
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