The following data is part of a premarket notification filed by J.t. Baker Chemical Co. with the FDA for Sulfanilic Acid.
Device ID | K760407 |
510k Number | K760407 |
Device Name: | SULFANILIC ACID |
Classification | Diazo Colorimetry, Bilirubin |
Applicant | J.T. BAKER CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CIG |
CFR Regulation Number | 862.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-09 |
Decision Date | 1976-10-29 |