The following data is part of a premarket notification filed by Verichem Laboratories, Inc. with the FDA for Matrix Plus(tm) Chemistry Reference Standard.
| Device ID | K901113 |
| 510k Number | K901113 |
| Device Name: | MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD |
| Classification | Calibrator, Primary |
| Applicant | VERICHEM LABORATORIES, INC. 3226 PAWTUCKET AVE. SUITE #1 East Providence, RI 02915 |
| Contact | Anthony J Dimonte |
| Correspondent | Anthony J Dimonte VERICHEM LABORATORIES, INC. 3226 PAWTUCKET AVE. SUITE #1 East Providence, RI 02915 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-07 |
| Decision Date | 1990-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852553007384 | K901113 | 000 |
| 00852553007339 | K901113 | 000 |
| 00852553007315 | K901113 | 000 |
| 00852553007292 | K901113 | 000 |
| 00852553007285 | K901113 | 000 |
| 00852553007223 | K901113 | 000 |
| 00852553007209 | K901113 | 000 |
| 00852553007148 | K901113 | 000 |
| 00852553007018 | K901113 | 000 |