The following data is part of a premarket notification filed by In-line Diagnostics Corp. with the FDA for Crit-scan Ii Monitor.
| Device ID | K983551 |
| 510k Number | K983551 |
| Device Name: | CRIT-SCAN II MONITOR |
| Classification | Instrument, Hematocrit, Automated |
| Applicant | IN-LINE DIAGNOSTICS CORP. 117 WEST 200 SOUTH Farmington, UT 84025 |
| Contact | Matthew L Haynie |
| Correspondent | Matthew L Haynie IN-LINE DIAGNOSTICS CORP. 117 WEST 200 SOUTH Farmington, UT 84025 |
| Product Code | GKF |
| CFR Regulation Number | 864.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-09 |
| Decision Date | 1999-05-27 |
| Summary: | summary |