FDA 510(k) Applications for Medical Device:
Plasma, Control, Normal

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K961814 CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR.
RALEIGH NC 27616
K023309 DADE BEHRING, INC. 514 GBC DR.
NEWARK DE 19702
K001256 DADE BEHRING, INC. PO BOX 6101
NEWARK DE 19714-6101
K042941 DADE BEHRING, INC. GLASCO B500 M.S. 514
NEWARK DE 19714-6101
K984129 PACIFIC HEMOSTASIS 11515 VANSTORY DR.
HUNTERSVILLE NC 28078-8144
K013708 PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100
DARTMOUTH, N.S. B3B 1P7
K003328 SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE.
ST. LOUIS MO 63103
K973274 SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE.
ST. LOUIS MO 63103
K060968 WORTHAM LABORATORIES INC 6340 BONNY OAKS DR.
CHATTANOOGA TN 37416




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