The following data is part of a premarket notification filed by In-line Diagnostics Corp. with the FDA for Crit-line Hematocrit Alert (modification).
| Device ID | K953875 |
| 510k Number | K953875 |
| Device Name: | CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) |
| Classification | System, Hemodialysis, Access Recirculation Monitoring |
| Applicant | IN-LINE DIAGNOSTICS CORP. 4646 S. 1500 W.,SUITE 160 Riverdale, UT 84405 |
| Contact | James M Conis |
| Correspondent | James M Conis IN-LINE DIAGNOSTICS CORP. 4646 S. 1500 W.,SUITE 160 Riverdale, UT 84405 |
| Product Code | MQS |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-28 |
| Decision Date | 1996-07-23 |