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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Platelet Counting, Manual
510(k) Number K811084
Device Name LABTRONIX PLATELET COUNTER(L/O/C.)
Applicant
Labtronix Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Labtronix Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.6160
Classification Product Code
GLG  
Date Received04/21/1981
Decision Date 07/23/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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