The following data is part of a premarket notification filed by Hema Metrics, Llc with the FDA for Crit-line Anemia Management Software.
| Device ID | K093834 |
| 510k Number | K093834 |
| Device Name: | CRIT-LINE ANEMIA MANAGEMENT SOFTWARE |
| Classification | Test, Urea (breath Or Blood) |
| Applicant | HEMA METRICS, LLC 136 W. 2ND ST. Ogden, UT 84404 |
| Contact | Terry Lanier |
| Correspondent | Terry Lanier HEMA METRICS, LLC 136 W. 2ND ST. Ogden, UT 84404 |
| Product Code | MSQ |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-14 |
| Decision Date | 2010-09-29 |
| Summary: | summary |