THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME— 510(k) K932153

Name: FDA 510(k) clearance K932153
Creator: U.S. Food and Drug Administration
Published: 1993-09-07

Substantially Equivalent

Biodan Medical Systems, Ltd.

FDA 510(k) clearance K932153 for THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME, Substantially Equivalent on 1993-09-07. Applicant: Biodan Medical Systems, Ltd.. Device class: 1.

Clearance details

Applicant: Biodan Medical Systems, Ltd.
Product code: Code IZD
Device class: Class 1
Regulation: 21 CFR 892.1320
Advisory panel: Radiology
Date received: 1993-05-04
Decision date: 1993-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shirley, NY, US

Download summary PDF View on FDA.gov ↗

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