The following data is part of a premarket notification filed by Accra Laboratories, Inc. with the FDA for Hemaquik.
| Device ID | K811400 | 
| 510k Number | K811400 | 
| Device Name: | HEMAQUIK | 
| Classification | Wright's Stain | 
| Applicant | ACCRA LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | IAF | 
| CFR Regulation Number | 864.1850 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1981-05-18 | 
| Decision Date | 1981-06-18 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  HEMAQUIK  73316003  1222245 Live/Registered | Accra Lab Inc. 1981-06-22 |