JSW — Kit, Identification, Glucose Nonfermenter Class I

FDA Device Classification

FDA product code JSW covers "Kit, Identification, Glucose Nonfermenter", a Class I medical device regulated under 21 CFR 866.2660. Submissions are reviewed by the Microbiology panel. At least 6 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JSW
Device Class
Class I
Regulation Number
866.2660
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K922768biomerieux vitekRAPID NFT, MODIFICATIONOctober 14, 1992
K900517innovative diagnostic systemsRAPID NF SYSTEMMarch 13, 1990
K870769austin biological laboratoriesAUSTIN NONFERMENTER KITApril 3, 1987
K790992micro-palettesPSEUDO-PALETTE TMJune 22, 1979
K772112corning medical and scientificNON-FERMENTER SYSTEMNovember 17, 1977
K770745micro-media systemsPANEL, GNF, MICRO-IDJune 23, 1977