The following data is part of a premarket notification filed by Maine Standards Co. with the FDA for Validate Chem 3 Calibration Verification Test Set, Model 10003.
| Device ID | K012119 |
| 510k Number | K012119 |
| Device Name: | VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MAINE STANDARDS CO. 765 ROOSEVELT TRAIL Windham, ME 04062 -5365 |
| Contact | Christine Beach |
| Correspondent | Christine Beach MAINE STANDARDS CO. 765 ROOSEVELT TRAIL Windham, ME 04062 -5365 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-06 |
| Decision Date | 2001-08-20 |
| Summary: | summary |