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FDA 510(k) Application Details - K022538
Device Classification Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
More FDA Info for this Device
510(K) Number
K022538
Device Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Applicant
DIAGNOSTIC CHEMICALS, LTD. (USA)
26371 EVA ST.
LAGUNA HILLS, CA 92656 US
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Contact
MIKE BERG
Other 510(k) Applications for this Contact
Regulation Number
862.1645
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Classification Product Code
JIR
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More FDA Info for this Product Code
Date Received
08/01/2002
Decision Date
08/23/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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