FDA 510(k) Application Details - K022603

Device Classification Name Radioimmunoassay, Parathyroid Hormone

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510(K) Number K022603
Device Name Radioimmunoassay, Parathyroid Hormone
Applicant DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES, CA 90045-5597 US
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Contact EDWARD M LEVINE
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Regulation Number 862.1545

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Classification Product Code CEW
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Date Received 08/06/2002
Decision Date 08/21/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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