The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Hemotec Hepcon Hms Coagulation System & Access..
| Device ID | K894317 |
| 510k Number | K894317 |
| Device Name: | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. |
| Classification | Analyzer, Heparin, Automated |
| Applicant | HEMOTEC, INC. 7103 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Contact | Taylor, M.s. |
| Correspondent | Taylor, M.s. HEMOTEC, INC. 7103 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Product Code | JOX |
| CFR Regulation Number | 864.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-09-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994909404 | K894317 | 000 |
| 20613994697169 | K894317 | 000 |
| 00763000014797 | K894317 | 000 |
| 00763000014780 | K894317 | 000 |
| 00763000014773 | K894317 | 000 |
| 00763000014766 | K894317 | 000 |
| 00763000014759 | K894317 | 000 |
| 00643169713253 | K894317 | 000 |
| 00643169713222 | K894317 | 000 |
| 00643169713215 | K894317 | 000 |
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| 00643169713192 | K894317 | 000 |
| 00643169713185 | K894317 | 000 |
| 00643169713178 | K894317 | 000 |
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| 20613994697176 | K894317 | 000 |
| 20613994697183 | K894317 | 000 |
| 20613994697190 | K894317 | 000 |
| 00681490512084 | K894317 | 000 |
| 00673978698793 | K894317 | 000 |
| 00721902433719 | K894317 | 000 |
| 00885074092904 | K894317 | 000 |
| 20613994923329 | K894317 | 000 |
| 20613994923312 | K894317 | 000 |
| 20613994923305 | K894317 | 000 |
| 20613994923299 | K894317 | 000 |
| 20613994923282 | K894317 | 000 |
| 20613994923275 | K894317 | 000 |
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| 20613994697220 | K894317 | 000 |
| 20613994697213 | K894317 | 000 |
| 20613994697206 | K894317 | 000 |
| 00643169713147 | K894317 | 000 |