FDA 510(k) Application Details - K990222

Device Classification Name System, Test, Human Chorionic Gonadotropin

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510(K) Number K990222
Device Name System, Test, Human Chorionic Gonadotropin
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 862.1155

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Classification Product Code DHA
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Date Received 01/25/1999
Decision Date 02/26/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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