The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Gc-lect(tm).
| Device ID | K864803 |
| 510k Number | K864803 |
| Device Name: | GC-LECT(TM) |
| Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Russell Arnsberger |
| Correspondent | Russell Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | JTY |
| CFR Regulation Number | 866.2410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-09 |
| Decision Date | 1987-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382902979280 | K864803 | 000 |
| 30382902977156 | K864803 | 000 |