The following data is part of a premarket notification filed by Anco Medical Reagents & Assoc. with the FDA for Sickle-heme A/s Controls & A/a Control.
| Device ID | K831871 |
| 510k Number | K831871 |
| Device Name: | SICKLE-HEME A/S CONTROLS & A/A CONTROL |
| Classification | Test, Sickle Cell |
| Applicant | ANCO MEDICAL REAGENTS & ASSOC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GHM |
| CFR Regulation Number | 864.7825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-13 |
| Decision Date | 1983-07-28 |