The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Paradigm Link Blood Glucose Meter.
| Device ID | K040603 |
| 510k Number | K040603 |
| Device Name: | PARADIGM LINK BLOOD GLUCOSE METER |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Contact | John Schalago |
| Correspondent | John Schalago BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-05 |
| Decision Date | 2004-05-19 |
| Summary: | summary |