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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, specimen collection
510(k) Number K900225
Device Name ROMCHECK SPECIMEN COLLECTION KIT
Applicant
ADEZA BIOMEDICAL
1240 ELKO DR.
SUNNYVALE,  CA  94089
Applicant Contact E CHARLTON,PHD
Correspondent
ADEZA BIOMEDICAL
1240 ELKO DR.
SUNNYVALE,  CA  94089
Correspondent Contact E CHARLTON,PHD
Regulation Number866.2900
Classification Product Code
LIO  
Date Received01/17/1990
Decision Date 02/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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