FDA 510(k) K885138, CAPILLARY TUBE, BLOOD COLLECTION, by Coeur Laboratories, Inc.
FDA 510(k) K885138, CAPILLARY TUBE, BLOOD COLLECTION, by Coeur Laboratories, Inc.
Device Classification Name: Tube, Collection, Capillary Blood
510(k) Number: K885138
Device Name: CAPILLARY TUBE, BLOOD COLLECTION
Applicant: Coeur Laboratories, Inc.
Regulation Number: 864.6150
Classification Product Code: GIO
Date Received: 12/15/1988
Decision Date: 02/07/1989
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
510k Review Panel: Hematology
Total number of pages: 8
Fully redacted pages: 2
Content pages: 6
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