HUMAN C-PEPTIDE REAGENTS— 510(k) K812288

Substantially Equivalent

Immunex Radiochemical Diagnostics

FDA 510(k) clearance K812288 for HUMAN C-PEPTIDE REAGENTS, Substantially Equivalent on 1981-08-31. Applicant: Immunex Radiochemical Diagnostics. Device class: 1.

Clearance details

Applicant
Immunex Radiochemical Diagnostics
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
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