FDA 510(k) Applications for Medical Device:
Immunoelectrophoretic, Immunoglobulins, (G, A, M)

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K002799 BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110
BREA CA 92822
K103757 GRIFOLS 150 CHERRY LANE ROAD
EAST STROUDSBURG PA 18301
K120169 GRIFOLS USA, LLC 482 CHERRY LANE RD.
EAST STROUDSBURG PA 18301
K990998 HELENA LABORATORIES 1530 LINDBERGH DR.
BEAUMONT TX 77704
K024162 HELENA LABORATORIES 1530 LINDBERGH DR.
BEAUMONT TX 77704
K061069 HELENA LABORATORIES 1530 LINDBERGH DR.
BEAUMONT TX 77704
K973040 HELENA LABORATORIES 1530 LINDBERGH DR.
BEAUMONT TX 77704
K111369 HELENA LABORATORIES UK LTD PO BOX 752, 1530 LINDEBERGH
BEAUMONT TX 77704-0752
K033187 INTERLAB S.R.L. 150 CHERRY LANE RD.
EAST STROUDSBURG PA 18301-8804
K993213 KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR.
SEATTLE WA 98188-3412
K993323 KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR.
SEATTLE WA 98188-3412
K981048 MORAX 13805 WATERLOO RD.
CHELSEA MI 48118
K033277 MORAX SUITE 400
NORCROSS GA 30093
K960669 MORAX 13805 WATERLOO RD.
CHELSEA MI 48118
K192095 Sebia 1705 Corporate Drive Suite 400
Norcross GA 30093
K161928 Sebia 1705 Corporate Drive, Suite 400
Norcross GA 30093
K082085 SEBIA 400-1705 CORPORATE DRIVE
NORCROSS GA 30093
K190851 Sebia 1705 Corporate Drive, Suite 400
Norcross GA 30093
K172195 Sebia 1705 Corporate Drive, Suite 400
Norcross GA 30093
K203184 Sebia 1705 Corporate Drive Suite 400
Norcross GA 30096
K143483 SEBIA 1705 CORPORATE DRIVE
NORCROSS GA 30093
K082388 SEBIA 400-1705 CORPORATE DRIVE
NORCROSS GA 30093




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