The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Bblcrystal Gram-positive Id System.
| Device ID | K961968 |
| 510k Number | K961968 |
| Device Name: | BBLCRYSTAL GRAM-POSITIVE ID SYSTEM |
| Classification | Gram Positive Identification Panel |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Contact | Virginia C Weinknecht |
| Correspondent | Virginia C Weinknecht BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Product Code | LQL |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-20 |
| Decision Date | 1997-02-04 |
| Summary: | summary |