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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 K973938
Device Name ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
Applicant
Sfri, Inc.
2082 Michelson Dr., #100
Irvine,  CA  92612 -1212
Applicant Contact GERALD ODSTRCHEL
Correspondent
Sfri, Inc.
2082 Michelson Dr., #100
Irvine,  CA  92612 -1212
Correspondent Contact GERALD ODSTRCHEL
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received10/15/1997
Decision Date 02/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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