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GSB — Antigens, Cf, All, Mycoplasma Spp. Class I

FDA Device Classification

Classification Details

Product Code
GSB
Device Class
Class I
Regulation Number
866.3375
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K852933microbix biosystemsMYCOPLASMA SPP SEROLOGICAL REAGENTSAugust 1, 1985
K843664institute virionMYCOPLASMA PNEUMONIAEOctober 25, 1984
K834338hillcrest biologicalsMYCOPLASMA PNEUMONIAE CF ANTIGENFebruary 27, 1984
K832132miles laboratoriesSERA-TEK MYCOPLASMA ANTIBODY TESTSeptember 20, 1983
K802934orion diagnosticaMYCOPLASMA PNEUMONIAE ANTIGEN & CONTROLDecember 31, 1980