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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 K900776
Device Name NOVAPATH MICROPLATE READER
Original Applicant
BIO-RAD
4000 alfred nobel dr.
hercules,  CA  94547 -1803
Original Contact trevor wall
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received02/20/1990
Decision Date 04/03/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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