The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for G7 Automated Hplc Analyzer.
| Device ID | K011434 |
| 510k Number | K011434 |
| Device Name: | G7 AUTOMATED HPLC ANALYZER |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | TOSOH MEDICS, INC. 347 OYSTER POINT BLVD., SUITE 201 San Francisco, CA 94080 |
| Contact | Lois Nakayama |
| Correspondent | Lois Nakayama TOSOH MEDICS, INC. 347 OYSTER POINT BLVD., SUITE 201 San Francisco, CA 94080 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-10 |
| Decision Date | 2001-09-18 |
| Summary: | summary |