FDA 510(k) Application Details - K823590

Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use

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510(K) Number K823590
Device Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant ORTHO DIAGNOSTIC SYSTEMS, INC.
125 MARK AVENUE
CARPINTERIA, CA US
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Regulation Number 862.2300

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Classification Product Code JJQ
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Date Received 12/06/1982
Decision Date 02/28/1983
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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