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FDA 510(k) Application Details - K013938
Device Classification Name
Acid, Lactic, Enzymatic Method
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510(K) Number
K013938
Device Name
Acid, Lactic, Enzymatic Method
Applicant
DIAMETRICS MEDICAL, INC.
2658 PATTON RD.
SAINT PAUL, MN 55113 US
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NANCY RING
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Regulation Number
862.1450
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Classification Product Code
KHP
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Date Received
11/28/2001
Decision Date
01/28/2002
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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