CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41— 510(k) K852023

Name: FDA 510(k) clearance K852023
Creator: U.S. Food and Drug Administration
Published: 1985-08-21

Substantially Equivalent

Syncor Intl. Corp.

FDA 510(k) clearance K852023 for CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41, Substantially Equivalent on 1985-08-21. Applicant: Syncor Intl. Corp.. Device class: 2.

Clearance details

Applicant: Syncor Intl. Corp.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1985-05-08
Decision date: 1985-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

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K945825 — SECURE SAFETY INSERT1995-04-10
K851828 — IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C1985-09-19
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K852665 — SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY1985-08-13
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