The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Alpha-thal Screen Tm Control.
| Device ID | K810976 |
| 510k Number | K810976 |
| Device Name: | ALPHA-THAL SCREEN TM CONTROL |
| Classification | Assay, Bart's, Hemoglobin |
| Applicant | ISOLAB, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LGL |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-10 |
| Decision Date | 1981-05-29 |