The following data is part of a premarket notification filed by Becton Dickinson Diagnostic Instrument Systems with the FDA for Bactec Fungal Medium.
Device ID | K954923 |
510k Number | K954923 |
Device Name: | BACTEC FUNGAL MEDIUM |
Classification | Monitor, Microbial Growth |
Applicant | BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
Contact | David R Mertz |
Correspondent | David R Mertz BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
Product Code | JTA |
CFR Regulation Number | 866.2560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-26 |
Decision Date | 1996-11-21 |
Summary: | summary |