The following data is part of a premarket notification filed by Becton Dickinson Diagnostic Instrument Systems with the FDA for Bactec Standard/10 Aerobic/f Culture Vials.
Device ID | K954921 |
510k Number | K954921 |
Device Name: | BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS |
Classification | System, Blood Culturing |
Applicant | BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
Contact | Dennis R Mertz |
Correspondent | Dennis R Mertz BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
Product Code | MDB |
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 | 1996-02-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30382904422609 | K954921 | 000 |