ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3— 510(k) K132828

Name: FDA 510(k) clearance K132828
Creator: U.S. Food and Drug Administration
Published: 2013-12-04

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K132828 for ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3, Substantially Equivalent on 2013-12-04. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JKR
Device class: Class 2
Regulation: 21 CFR 862.1140
Advisory panel: Clinical Chemistry
Date received: 2013-09-09
Decision date: 2013-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K990073 — CALCITONIN1999-05-11

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