The following data is part of a premarket notification filed by Sebia with the FDA for Minicap Hemoglobin(e) Kit, Model 2207, 2227.
| Device ID | K082227 |
| 510k Number | K082227 |
| Device Name: | MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 |
| Classification | Abnormal Hemoglobin Quantitation |
| Applicant | SEBIA 400-1705 CORPORATE DRIVE SUITE 400 Norcross, GA 30093 |
| Contact | Karen Anderson |
| Correspondent | Karen Anderson SEBIA 400-1705 CORPORATE DRIVE SUITE 400 Norcross, GA 30093 |
| Product Code | GKA |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-07 |
| Decision Date | 2009-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607360022078 | K082227 | 000 |