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FDA 510(k) Applications Submitted by ROY LAYER
FDA 510(k) Number
Submission Date
Device Name
Applicant
K090109
01/15/2009
BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
EPOCAL, INC.
K061597
06/08/2006
EPOC BLOOD ANALYSIS SYSTEM
EPOCAL, INC.
K092849
09/16/2009
BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
EPOCAL, INC.
K093297
10/21/2009
EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
EPOCAL, INC.
K113726
12/19/2011
EPOC CHLORIDE TEST AND EPOC CREATININE TEST
EPOCAL, INC.
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