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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 clinical use
510(k) Number BK010043
Tradename Atago SP-D2 Refractometer
Device Name Refractometer for Clinical Use
Original Applicant
VEEGEE Scientific
13600 ne 126th place
suite a
kirkland,  WA  98034
Regulation Number862.2800
Classification Product Code
JRE  
Date Received10/11/2001
Decision Date 01/02/2002
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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