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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Column Chromatography & Color Development, Hydroxyproline
510(k) Number K972788
Device Name CROSSLAPS ELISA
Applicant
Devices and Diagnostics Consulting Group
16809 Briardale Rd.
Rockville,  MD  20855
Applicant Contact TOM TSAKARIS
Correspondent
Devices and Diagnostics Consulting Group
16809 Briardale Rd.
Rockville,  MD  20855
Correspondent Contact TOM TSAKARIS
Regulation Number862.1400
Classification Product Code
JMM  
Date Received07/28/1997
Decision Date 12/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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