The following data is part of a premarket notification filed by J. D. Assoc. with the FDA for Ureafast.
Device ID | K863076 |
510k Number | K863076 |
Device Name: | UREAFAST |
Classification | Berthelot Indophenol, Urea Nitrogen |
Applicant | J. D. ASSOC. 163 MONTCLAIR AVE. Montclair, NJ 07042 |
Contact | Di Pietro |
Correspondent | Di Pietro J. D. ASSOC. 163 MONTCLAIR AVE. Montclair, NJ 07042 |
Product Code | CDL |
CFR Regulation Number | 862.1770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-12 |
Decision Date | 1986-09-09 |