C-PEPTIDE RADIOIMMUNOASSAY TEST KIT— 510(k) K833396
Substantially EquivalentSerono Diagnostics, Inc.
FDA 510(k) clearance K833396 for C-PEPTIDE RADIOIMMUNOASSAY TEST KIT, Substantially Equivalent on 1984-04-13. Applicant: Serono Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Serono Diagnostics, Inc.
- Product code
- Code JKD
- Device class
- Class 1
- Regulation
- 21 CFR 862.1135
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code JKD
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