PHEM-ALERT— 510(k) K012230

Substantially Equivalent

Femtek,Llc.

FDA 510(k) clearance K012230 for PHEM-ALERT, Substantially Equivalent on 2001-10-09. Applicant: Femtek,Llc..

Clearance details

Applicant
Femtek,Llc.
Product code
Code LNW
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rockville, MD, US
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