The following data is part of a premarket notification filed by Maine Standards Company Llc with the FDA for Validate Ferritin Calibration Verification/ Linearity Test Kit.
| Device ID | K133550 |
| 510k Number | K133550 |
| Device Name: | VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | MAINE STANDARDS COMPANY LLC 221 US ROUTE 1 Cumberland Foreside, ME 04110 |
| Contact | James W Champlin |
| Correspondent | James W Champlin MAINE STANDARDS COMPANY LLC 221 US ROUTE 1 Cumberland Foreside, ME 04110 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-19 |
| Decision Date | 2014-02-05 |
| Summary: | summary |