The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Clottrac(tm) Ibex Heparinase Hr Act Cart./control.
| Device ID | K902081 |
| 510k Number | K902081 |
| Device Name: | CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL |
| Classification | Activated Whole Blood Clotting Time |
| Applicant | HEMOTEC, INC. 7103 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Contact | Baugh, Phd |
| Correspondent | Baugh, Phd HEMOTEC, INC. 7103 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Product Code | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-08 |
| Decision Date | 1990-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20763000014821 | K902081 | 000 |
| 20643169713264 | K902081 | 000 |
| 00763000441456 | K902081 | 000 |