The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Bbl Ninhydrin Reagent Droppers.
Device ID | K926256 |
510k Number | K926256 |
Device Name: | BBL NINHYDRIN REAGENT DROPPERS |
Classification | Discs, Strips And Reagents, Microorganism Differentiation |
Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
Contact | Robert E James |
Correspondent | Robert E James BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
Product Code | JTO |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-18 |
Decision Date | 1993-01-26 |