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FDA 510(k) Application Details - K984067
Device Classification Name
Fluorometric Method, Cpk Or Isoenzymes
More FDA Info for this Device
510(K) Number
K984067
Device Name
Fluorometric Method, Cpk Or Isoenzymes
Applicant
DADE BEHRING, INC.
GLASGOW SITE
P.O. BOX 6101
NEWARK, DE 19714-6101 US
Other 510(k) Applications for this Company
Contact
REBECCA S AYASH
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
11/16/1998
Decision Date
01/13/1999
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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