The following data is part of a premarket notification filed by Anco Medical Reagents & Assoc. with the FDA for Sickle Cell Stat A/s Heterozygous-eryth.
| Device ID | K842440 |
| 510k Number | K842440 |
| Device Name: | SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH |
| Classification | Mixture, Hematology Quality Control |
| Applicant | ANCO MEDICAL REAGENTS & ASSOC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-21 |
| Decision Date | 1984-07-27 |