The following data is part of a premarket notification filed by Accra Laboratories, Inc. with the FDA for Hemacount Wright Giemsa Stain Pack.
| Device ID | K822602 |
| 510k Number | K822602 |
| Device Name: | HEMACOUNT WRIGHT GIEMSA STAIN PACK |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | ACCRA LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-27 |
| Decision Date | 1982-09-17 |