The following data is part of a premarket notification filed by Hitachi Chemical Diagnostics, Inc. with the FDA for S Test Reagent Cartridge Alp (alkaline Phosphatase).
| Device ID | K130141 |
| 510k Number | K130141 |
| Device Name: | S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | HITACHI CHEMICAL DIAGNOSTICS, INC. 630 CLYDE COURT Mountain View, CA 94043 |
| Contact | Erika B Ammirati, Rac, Mt (ascp) |
| Correspondent | Erika B Ammirati, Rac, Mt (ascp) HITACHI CHEMICAL DIAGNOSTICS, INC. 630 CLYDE COURT Mountain View, CA 94043 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-22 |
| Decision Date | 2013-03-22 |
| Summary: | summary |