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FDA 510(k) Application Details - K034055
Device Classification Name
Fluorometric Method, Cpk Or Isoenzymes
More FDA Info for this Device
510(K) Number
K034055
Device Name
Fluorometric Method, Cpk Or Isoenzymes
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES, CA 90045-5597 US
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Contact
EDWARD M LEVINE, PH.D.
Other 510(k) Applications for this Contact
Regulation Number
862.1215
More FDA Info for this Regulation Number
Classification Product Code
JHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/30/2003
Decision Date
01/21/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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