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LJY — Enzyme Linked Immunoabsorbent Assay, Mumps Virus Class I

FDA Device Classification

Classification Details

Product Code
LJY
Device Class
Class I
Regulation Number
866.3380
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K991274columbia bioscienceMUMPS IGG ELISA TEST SYSTEMSeptember 3, 1999
K980059quest intlSERAQUEST MUMPS IGGApril 23, 1998
K971857gull laboratoriesMUMPS IGG ELISA TESTYNovember 4, 1997
K961204zeus scientificMUMPS IGG TESTJuly 18, 1996
K925209biowhittaker molecular applicationsMUMPS STATOctober 14, 1994
K923903biomerieux vitekVITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSAAugust 9, 1993
K897006pharmacia eni diagnosticsPHARMACIA MUMPS IGG ELISAJuly 26, 1990
K830045m.a. bioproductsMUMPSELISA TEST KITMay 13, 1983