The following data is part of a premarket notification filed by Future Impex Corp. with the FDA for Te-25 Coaguro Meter.
| Device ID | K854686 |
| 510k Number | K854686 |
| Device Name: | TE-25 COAGURO METER |
| Classification | Activated Whole Blood Clotting Time |
| Applicant | FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deerpark, NY 11729 |
| Contact | Morad Davoudzadeh |
| Correspondent | Morad Davoudzadeh FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deerpark, NY 11729 |
| Product Code | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-20 |
| Decision Date | 1986-06-04 |