The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Bblcrystal Anaerobe Id System.
| Device ID | K944528 |
| 510k Number | K944528 |
| Device Name: | BBLCRYSTAL ANAEROBE ID SYSTEM |
| Classification | Kit, Anaerobic Identification |
| Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Product Code | JSP |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-15 |
| Decision Date | 1995-03-07 |