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GOM — Antisera, Cf, Rubella Class II

FDA Device Classification

Classification Details

Product Code
GOM
Device Class
Class II
Regulation Number
866.3510
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K954515pyramid biologicalENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLADecember 20, 1995
K953826pyramid biologicalENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLADecember 14, 1995