The following data is part of a premarket notification filed by Eppendorf-brinkmann, Inc. with the FDA for Urinary Vma - Screen Test Kit.
Device ID | K772151 |
510k Number | K772151 |
Device Name: | URINARY VMA - SCREEN TEST KIT |
Classification | Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin |
Applicant | EPPENDORF-BRINKMANN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CDF |
CFR Regulation Number | 862.1795 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-11-15 |
Decision Date | 1977-11-30 |