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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Automated Cell-Locating
510(k) Number K973050
Device Name MICRO21 WITH WBC ESTIMATE
Applicant
Triangle Biomedical Sciences, Inc.
4360 Northlake Blvd., #100
Palm Beach Gardens,  FL  33410
Applicant Contact R. OTTO STELLNER
Correspondent
Triangle Biomedical Sciences, Inc.
4360 Northlake Blvd., #100
Palm Beach Gardens,  FL  33410
Correspondent Contact R. OTTO STELLNER
Regulation Number864.5260
Classification Product Code
JOY  
Date Received08/15/1997
Decision Date 11/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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