The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Volu-sol Stat Stain.
Device ID | K792017 |
510k Number | K792017 |
Device Name: | VOLU-SOL STAT STAIN |
Classification | Wright's Stain |
Applicant | VOLU SOL MEDICAL INDUSTRIES 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 | 1979-10-09 |
Decision Date | 1979-10-30 |