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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Multiple Biochemical Test
510(k) Number K883996
Device Name X-ACT LDC/IND
Applicant
Pro-Lab, Inc.
290 Larkin St.
P.O. Box 1099
Buffalo,  NY  14210
Applicant Contact KAY BAITZ
Correspondent
Pro-Lab, Inc.
290 Larkin St.
P.O. Box 1099
Buffalo,  NY  14210
Correspondent Contact KAY BAITZ
Regulation Number866.2320
Classification Product Code
JSE  
Date Received09/20/1988
Decision Date 10/12/1988
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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