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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, Non-Selective And Non-Differential
510(k) Number K870133
Device Name HY PBC FLASK
Applicant
Hy Laboratories, Ltd.
Kiryat Weizmann
Rehovot 76326,  IL
Applicant Contact AVNER SHENFELD
Correspondent
Hy Laboratories, Ltd.
Kiryat Weizmann
Rehovot 76326,  IL
Correspondent Contact AVNER SHENFELD
Regulation Number866.2300
Classification Product Code
JSG  
Date Received01/12/1987
Decision Date 02/05/1987
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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