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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Quality Control For Culture Media
510(k) Number K871121
Device Name PROTECT T.M.
Applicant
Pro-Lab, Inc.
705 Progress Ave. Unit 3a
Scarborough Ont,  CA
Applicant Contact LYNN RAE
Correspondent
Pro-Lab, Inc.
705 Progress Ave. Unit 3a
Scarborough Ont,  CA
Correspondent Contact LYNN RAE
Regulation Number866.2480
Classification Product Code
JTR  
Date Received03/19/1987
Decision Date 04/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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