The following data is part of a premarket notification filed by Sure-tech Diagnostic Associates, Inc. with the FDA for Fetal Hemoglobin.
| Device ID | K892241 |
| 510k Number | K892241 |
| Device Name: | FETAL HEMOGLOBIN |
| Classification | Stain, Fetal Hemoglobin |
| Applicant | SURE-TECH DIAGNOSTIC ASSOCIATES, INC. 11012 LIN VALLE DR., SUITE D St. Louis, MO 63123 |
| Contact | Quincy E Crider,phd |
| Correspondent | Quincy E Crider,phd SURE-TECH DIAGNOSTIC ASSOCIATES, INC. 11012 LIN VALLE DR., SUITE D St. Louis, MO 63123 |
| Product Code | GHQ |
| CFR Regulation Number | 864.7455 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-22 |
| Decision Date | 1989-05-17 |