The following data is part of a premarket notification filed by J.t. Baker Chemical Co. with the FDA for Reagent, Amp Buffer Diagnostic.
| Device ID | K760397 |
| 510k Number | K760397 |
| Device Name: | REAGENT, AMP BUFFER DIAGNOSTIC |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | J.T. BAKER CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-06 |
| Decision Date | 1976-11-01 |