The following data is part of a premarket notification filed by E K Ind., Inc. with the FDA for Wright-giemsa Quick Stain.
Device ID | K842745 |
510k Number | K842745 |
Device Name: | WRIGHT-GIEMSA QUICK STAIN |
Classification | Wright's Stain |
Applicant | E K IND., 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 | 1984-07-13 |
Decision Date | 1984-08-10 |