The following data is part of a premarket notification filed by Sebia with the FDA for Capillary's Hemoglobin(e) (pn 2007).
| Device ID | K052291 |
| 510k Number | K052291 |
| Device Name: | CAPILLARY'S HEMOGLOBIN(E) (PN 2007) |
| Classification | Abnormal Hemoglobin Quantitation |
| Applicant | SEBIA 13805 WATERLOO Chelsea, MI 48118 |
| Contact | Karen Anderson |
| Correspondent | Karen Anderson SEBIA 13805 WATERLOO Chelsea, MI 48118 |
| Product Code | GKA |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-23 |
| Decision Date | 2006-06-27 |
| Summary: | summary |