FDA 510(k) Application Details - K841809

Device Classification Name Mixture, Hematology Quality Control

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510(K) Number K841809
Device Name Mixture, Hematology Quality Control
Applicant DIAGNOSTIC TECHNOLOGY, INC.
240 VANDERBILT MOTOR PKWY.
HAUPPAUGE, NY US
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Contact ROBERT E LIND
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Regulation Number 864.8625

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Classification Product Code JPK
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Date Received 05/01/1984
Decision Date 11/30/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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