FDA 510(k) K982999, GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE, by Greiner Meditech, Inc.
FDA 510(k) K982999, GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE, by Greiner Meditech, Inc.
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number: K982999
Device Name: GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE
Applicant: Greiner Meditech, Inc.
Regulation Number: 862.1675
Classification Product Code: JKA
Date Received: 08/27/1998
Decision Date: 10/16/1998
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
510k Review Panel: Clinical Chemistry
Total number of pages: 69
Fully redacted pages: 23
Content pages: 46
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