FDA 510(k) Application Details - K960171

Device Classification Name Column Chromatography & Color Development, Hydroxyproline

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510(K) Number K960171
Device Name Column Chromatography & Color Development, Hydroxyproline
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER, TX 77598 US
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Contact JOHN WILLIS
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Regulation Number 862.1400

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Classification Product Code JMM
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Date Received 01/16/1996
Decision Date 03/28/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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