The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Multi-chem Calibrator A.
| Device ID | K042551 |
| 510k Number | K042551 |
| Device Name: | MULTI-CHEM CALIBRATOR A |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Contact | Lori Creasy |
| Correspondent | Lori Creasy WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-20 |
| Decision Date | 2004-11-16 |