FDA 510(k) Application Details - K761308

Device Classification Name Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.

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510(K) Number K761308
Device Name Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.
Applicant MEDLINE INDUSTRIES, INC.

, US
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Regulation Number 862.3320

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Classification Product Code DPD
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Date Received 12/23/1976
Decision Date 01/06/1977
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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