NEW DETECTOR FOR TRANSCAM/POLARIS S315— 510(k) K924639

Name: FDA 510(k) clearance K924639
Creator: U.S. Food and Drug Administration
Published: 1993-01-15

Substantially Equivalent

Adac Laboratories

FDA 510(k) clearance K924639 for NEW DETECTOR FOR TRANSCAM/POLARIS S315, Substantially Equivalent on 1993-01-15. Applicant: Adac Laboratories. Device class: 1.

Clearance details

Applicant: Adac Laboratories
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 1992-09-02
Decision date: 1993-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Download summary PDF View on FDA.gov ↗

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