The following data is part of a premarket notification filed by General Atomics with the FDA for Hba1c Enzymatic Assay.
| Device ID | K050178 |
| 510k Number | K050178 |
| Device Name: | HBA1C ENZYMATIC ASSAY |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | GENERAL ATOMICS 3550 GENERAL ATOMICS COURT San Diego, CA 92121 |
| Contact | Huan Tran |
| Correspondent | Huan Tran GENERAL ATOMICS 3550 GENERAL ATOMICS COURT San Diego, CA 92121 |
| Product Code | LCP |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-26 |
| Decision Date | 2005-06-28 |
| Summary: | summary |