MXB — Test, Vaginal, Bacterial Sialidase Class I

FDA Device Classification

FDA product code MXB covers "Test, Vaginal, Bacterial Sialidase", a Class I medical device regulated under 21 CFR 866.2660. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MXB
Device Class
Class I
Regulation Number
866.2660
Submission Type
510(k) Exempt
Review Panel
CH
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K050755Gryphus DiagnosticsMODIFICATION TO BVBLUEApr 6, 2005
K993732Gryphus DiagnosticsBVBLUEMay 15, 2000

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.