FDA 510(k) Application Details - K842099

Device Classification Name Calibrator, Secondary

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510(K) Number K842099
Device Name Calibrator, Secondary
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC.


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Regulation Number 862.1150

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Classification Product Code JIT
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Date Received 05/25/1984
Decision Date 08/17/1984
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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