The following data is part of a premarket notification filed by Becton Dickinson Diagnostic Instrument Systems with the FDA for Bactec Peds Plus/f Culture Vials.
| Device ID | K954927 |
| 510k Number | K954927 |
| Device Name: | BACTEC PEDS PLUS/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 |
|---|---|---|
| 30382904421947 | K954927 | 000 |