FDA 510(k) Applications for Medical Device Product Code "LJY"
(Enzyme Linked Immunoabsorbent Assay, Mumps Virus)

FDA 510(k) Number Applicant Device Name Decision Date
K991274 COLUMBIA BIOSCIENCE, INC. MUMPS IGG ELISA TEST SYSTEM 09/03/1999
K971857 GULL LABORATORIES, INC. MUMPS IGG ELISA TESTY 11/04/1997
K980059 QUEST INTL., INC. SERAQUEST MUMPS IGG 04/23/1998
K961204 ZEUS SCIENTIFIC, INC. MUMPS IGG TEST 07/18/1996


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