The following data is part of a premarket notification filed by Exel Intl. with the FDA for Vacuum Blood Collecting System (neo-tube).
| Device ID | K861449 |
| 510k Number | K861449 |
| Device Name: | VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) |
| Classification | Tubes, Vacuum Sample, With Anticoagulant |
| Applicant | EXEL INTL. 2300 E. OAKLAND PARK BLVD., SUITE 205/6 Fort Lauderdale, FL 33306 |
| Contact | Eshagh Hamid |
| Correspondent | Eshagh Hamid EXEL INTL. 2300 E. OAKLAND PARK BLVD., SUITE 205/6 Fort Lauderdale, FL 33306 |
| Product Code | GIM |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-17 |
| Decision Date | 1986-09-16 |