The following data is part of a premarket notification filed by Tosoh Bioscience, Inc. with the FDA for St Aia Pack Hba1c.
| Device ID | K100304 |
| 510k Number | K100304 |
| Device Name: | ST AIA PACK HBA1C |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | Tosoh BioScience, Inc. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Contact | Judith Ogden |
| Correspondent | Judith Ogden Tosoh BioScience, Inc. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Product Code | LCP |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-03 |
| Decision Date | 2010-08-27 |
| Summary: | summary |