FDA 510(k) Application Details - K770411

Device Classification Name Digoxin Control Serum, Ria

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510(K) Number K770411
Device Name Digoxin Control Serum, Ria
Applicant NUCLEAR MEDICAL LABORATORIES, INC.

, US
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Regulation Number 862.3280

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Classification Product Code DMP
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Date Received 03/04/1977
Decision Date 03/16/1977
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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