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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cryptosporidium Spp.
510(k) Number K980354
Device Name CRYPTOSPORIDIUM TEST
Applicant
Techlab, Inc.
1861 Pratt Dr., Suite 1030
Blacksburg,  VA  24060
Applicant Contact DAVID M LYERLY, PH.D.
Correspondent
Techlab, Inc.
1861 Pratt Dr., Suite 1030
Blacksburg,  VA  24060
Correspondent Contact DAVID M LYERLY, PH.D.
Regulation Number866.3220
Classification Product Code
MHJ  
Date Received01/29/1998
Decision Date 05/18/1998
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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