The following data is part of a premarket notification filed by Alta Diagnostics, Inc. with the FDA for Fetal Check.
| Device ID | K792546 |
| 510k Number | K792546 |
| Device Name: | FETAL CHECK |
| Classification | Erythrosin B |
| Applicant | ALTA DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KJR |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-10 |
| Decision Date | 1979-12-18 |