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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 K983119
FOIA Releasable 510(k) K983119
Device Name ENTERO-TEST HP, MODEL #102-01
Applicant
Hdc Corp.
2109 O'Toole Ave.
San Jose,  CA  95131
Applicant Contact LEN ROSS
Correspondent
Hdc Corp.
2109 O'Toole Ave.
San Jose,  CA  95131
Correspondent Contact LEN ROSS
Regulation Number866.2900
Classification Product Code
LIO  
Date Received09/08/1998
Decision Date 03/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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