FDA 510(k) K093297, EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE, by Epocal, Inc.
FDA 510(k) K093297, EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE, by Epocal, Inc.
Device Classification Name: Acid, Lactic, Enzymatic Method
510(k) Number: K093297
Device Name: EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
Applicant: Epocal, Inc.
Regulation Number: 862.145
Classification Product Code: KHP
Date Received: 2009-10-21
Decision Date: 2010-06-09
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
510k Review Panel: Clinical Chemistry
Total number of pages: 2,011
Fully redacted pages: 1,734
Content pages: 277
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