The following data is part of a premarket notification filed by J.s. Medical Assoc. with the FDA for Quick Stain Wright's Giemsa W/buff.
Device ID | K833677 |
510k Number | K833677 |
Device Name: | QUICK STAIN WRIGHT'S GIEMSA W/BUFF |
Classification | Giemsa Stain |
Applicant | J.S. MEDICAL ASSOC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HYF |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-18 |
Decision Date | 1983-11-25 |