FDA 510(k) Application Details - K853532

Device Classification Name Calibrators, Ethyl Alcohol

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510(K) Number K853532
Device Name Calibrators, Ethyl Alcohol
Applicant DIAGNOSTIC SYSTEMS
480 DEMOCRAT RD.
GIBBSTOWN, NJ US
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Contact RAYMOND L MILLER
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Regulation Number 862.3200

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Classification Product Code DNN
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Date Received 08/23/1985
Decision Date 09/16/1985
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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