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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Vacuette Blood Collection Tubes Serum with Clot Activator; Vacuette Blood Collection Tubes Serum with Clot Activator and Gel
Classification Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
Product Code: JKA
Device Class: 2
Regulation Number: 862.1675
Medical Specialty: Clinical Chemistry
Registered Establishment Name: GREINER BIO-ONE GMBH
Registered Establishment Number: 8020040
Premarket Submission Number: K960858
Owner/Operator: GREINER BIO-ONE NA
Owner/Operator Number: 8020040
Establishment Operations: Manufacturer; Specification Developer
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