FDA 510(k) K931368, MICROTAINER BRAND TUBE WITH EDTA, by Bd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) K931368, MICROTAINER BRAND TUBE WITH EDTA, by Bd Becton Dickinson Vacutainer Systems Preanalytic
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number: K931368
Device Name: MICROTAINER BRAND TUBE WITH EDTA
Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Regulation Number: 862.1675
Classification Product Code: JKA
Date Received: 03/17/1993
Decision Date: 09/28/1993
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
510k Review Panel: Clinical Chemistry
Total number of pages: 118
Fully redacted pages: 42
Content pages: 76
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