FDA 510(k) K853152, MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR, by Sherwood Medical Co.
FDA 510(k) K853152, MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR, by Sherwood Medical Co.
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number: K853152
Device Name: MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR
Applicant: Sherwood Medical Co.
Regulation Number: 862.1675
Classification Product Code: JKA
Date Received: 07/29/1985
Decision Date: 08/23/1985
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
510k Review Panel: Clinical Chemistry
Total number of pages: 40
Fully redacted pages: 20
Content pages: 20
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