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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme immunoassay, cortisol, salivary
510(k) Number K031348
Device Name HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY
Applicant
SALIMETRICS LLC.
101 INNOVATION BLVD.
SUITE 302
STATE COLLEGE,  PA  16803 -6605
Applicant Contact EVE SCHWARTZ
Correspondent
SALIMETRICS LLC.
101 INNOVATION BLVD.
SUITE 302
STATE COLLEGE,  PA  16803 -6605
Correspondent Contact EVE SCHWARTZ
Regulation Number862.1205
Classification Product Code
NHG  
Date Received04/11/2003
Decision Date 06/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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