The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Facs Sample Prep Assistant Iii.
| Device ID | K131301 |
| 510k Number | K131301 |
| Device Name: | BD FACS SAMPLE PREP ASSISTANT III |
| Classification | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis |
| Applicant | BECTON DICKINSON & CO. 2350 Qume Drive San Jose, CA 95131 |
| Contact | Kimberly Liedtke |
| Correspondent | Kimberly Liedtke BECTON DICKINSON & CO. 2350 Qume Drive San Jose, CA 95131 |
| Product Code | PER |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-07 |
| Decision Date | 2013-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382906472052 | K131301 | 000 |