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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K914129
Device Name DIFF SAFE
Applicant
Marshall Levinson
96 Drummers Ln.
Wayne,  PA  19087
Applicant Contact MARSHALL LEVINE
Correspondent
Marshall Levinson
96 Drummers Ln.
Wayne,  PA  19087
Correspondent Contact MARSHALL LEVINE
Regulation Number862.1675
Classification Product Code
JKA  
Date Received09/13/1991
Decision Date 10/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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