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 |