The following data is part of a premarket notification filed by J.t. Baker Chemical Co. with the FDA for Baker Diag. Ultrarate Chloride Kit.
Device ID | K802080 |
510k Number | K802080 |
Device Name: | BAKER DIAG. ULTRARATE CHLORIDE KIT |
Classification | Coulometric, Chloride |
Applicant | J.T. BAKER CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JFS |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-28 |
Decision Date | 1980-10-10 |