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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
510(k) Number K981865
Device Name MTM BIOSCANNER K TEST STRIPS
Applicant
Polymer Technology Systems, Inc.
7736 Zionsville Rd.
Indianapolis,  IN  46268
Applicant Contact MARGO ENRIGHT
Correspondent
Polymer Technology Systems, Inc.
7736 Zionsville Rd.
Indianapolis,  IN  46268
Correspondent Contact MARGO ENRIGHT
Regulation Number862.1380
Classification Product Code
JMK  
Date Received05/28/1998
Decision Date 02/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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