FDA 510(k) Applications for Medical Device:
Enzyme Linked Immunoabsorbent Assay, Rotavirus

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K972895 BIOMERIEUX VITEK, INC. 1022 HINGHAM ST.
ROCKLAND MA 02370
K965092 BIOMERIEUX VITEK, INC. 1022 HINGHAM ST.
ROCKLAND MA 02370
K951208 ELDAN TECHNOLOGIES, LTD. P.O. BOX 1270
JERUSALEM 91012
K971585 MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR.
CINCINNATI OH 45244
K990842 SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL
SAN ANTONIO TX 78240
K964424 TRINITY BIOTECH, INC. 3722 AVE. SAUSALILO
IRVINE CA 92606-1849




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