FDA 510(k) Application Details - K780495

Device Classification Name Digitoxin Control Serum, Ria

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510(K) Number K780495
Device Name Digitoxin Control Serum, Ria
Applicant DIAGNOSTIC PRODUCTS CORP.

, US
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Regulation Number 862.3280

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Classification Product Code DJK
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Date Received 03/27/1978
Decision Date 04/10/1978
Decision SE - Substantially Equivalent
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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