Home / Device Classification / GSA

GSA — Antisera, All Mycoplasma Spp. Class I

FDA Device Classification

Classification Details

Product Code
GSA
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
K950073shared systemsMYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEMOctober 17, 1995
K910833seradynCOLOR VUE TM- MYCOPLASMA PNEUMONIAEJune 24, 1991
K905493meridian diagnosticsMERISTAR-MPJanuary 30, 1991
K903958intl. mycoplasma/mdc assocSEROFASTDecember 21, 1990
K883083medical diagnostic technologiesMYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEMOctober 25, 1988
K862630medical diagnostic technologiesMYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEMSeptember 3, 1986