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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K941394
Device Name STAT FAX 2600
Applicant
Awareness Technology, Inc.
1995 SW Martin Hwy.
P.O. Box 1679
Palm City,  FL  34990
Applicant Contact MARY FREEMAN
Correspondent
Awareness Technology, Inc.
1995 SW Martin Hwy.
P.O. Box 1679
Palm City,  FL  34990
Correspondent Contact MARY FREEMAN
Regulation Number862.2750
Classification Product Code
JQW  
Date Received03/22/1994
Decision Date 06/03/1994
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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