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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 K051733
Device Name ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
Applicant
Drg Intl., Inc.
150 Cherry Lane Rd.
East Stroudsburg,  PA  18301
Applicant Contact Gary Lehnus
Correspondent
Drg Intl., Inc.
150 Cherry Lane Rd.
East Stroudsburg,  PA  18301
Correspondent Contact Gary Lehnus
Regulation Number862.1205
Classification Product Code
NHG  
Date Received06/28/2005
Decision Date 12/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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