The following data is part of a premarket notification filed by Toa Medical Electronics Usa, Inc. with the FDA for Hemoglobin Reagent.
| Device ID | K910745 |
| 510k Number | K910745 |
| Device Name: | HEMOGLOBIN REAGENT |
| Classification | System, Hemoglobin, Automated |
| Applicant | TOA MEDICAL ELECTRONICS USA, INC. 4410 CERRITOS AVE. Los Alamitos, CA 90720 |
| Contact | Robert W Pearson |
| Correspondent | Robert W Pearson TOA MEDICAL ELECTRONICS USA, INC. 4410 CERRITOS AVE. Los Alamitos, CA 90720 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-21 |
| Decision Date | 1991-07-11 |