The following data is part of a premarket notification filed by Trace America, Inc. with the FDA for Resubmitted Alkaline Phosphatase Reagent Amp Buff..
| Device ID | K880795 |
| 510k Number | K880795 |
| Device Name: | RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | TRACE AMERICA, INC. P.O. BOX 45-1835 Miami, FL 33245 |
| Contact | Ray Lopez |
| Correspondent | Ray Lopez TRACE AMERICA, INC. P.O. BOX 45-1835 Miami, FL 33245 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-26 |
| Decision Date | 1988-04-18 |