The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Microtainer Brand Sodium Fluoride/edta Tube With Microgard Closure, Model 365992.
| Device ID | K002456 |
| 510k Number | K002456 |
| Device Name: | MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Contact | James Haynes |
| Correspondent | James Haynes BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-10 |
| Decision Date | 2000-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903659925 | K002456 | 000 |
| 30382903659921 | K002456 | 000 |