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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K850994
Device Name SPECTRA 1 FILTER PHOTOMETER
Applicant
Awareness Technology, Inc.
3481 SW Palm City Sch. Rd.
P.O. Box 1679
Palm City,  FL  34990
Applicant Contact MARY FREEMAN
Correspondent
Awareness Technology, Inc.
3481 SW Palm City Sch. Rd.
P.O. Box 1679
Palm City,  FL  34990
Correspondent Contact MARY FREEMAN
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received03/11/1985
Decision Date 05/10/1985
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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