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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name refractometer for donor testing
510(k) Number BK170128
Tradename TS Meter-DSP
Device Name Refractometer for donor testing
Original Applicant
Reichert Inc.
3362 walden ave
suite 100
depew,  NY  14043
Regulation Number862.2800
Classification Product Code
PSM  
Date Received10/02/2017
Decision Date 12/19/2017
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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