The following data is part of a premarket notification filed by Verichem Laboratories, Inc. with the FDA for Matrix Plus Multi-calibrator Kit.
| Device ID | K973345 |
| 510k Number | K973345 |
| Device Name: | MATRIX PLUS MULTI-CALIBRATOR KIT |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | VERICHEM LABORATORIES, INC. 90 NARRAGANSETT AVE. Providence, RI 02907 |
| Contact | Anthony J Dimonte |
| Correspondent | Anthony J Dimonte VERICHEM LABORATORIES, INC. 90 NARRAGANSETT AVE. Providence, RI 02907 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-05 |
| Decision Date | 1997-10-29 |