The following data is part of a premarket notification filed by Maine Standards Company, Llc with the FDA for Validate Anemia Calibration Verification/ Linearity Test Kit.
| Device ID | K142964 |
| 510k Number | K142964 |
| Device Name: | VALIDATE Anemia Calibration Verification/ Linearity Test Kit |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MAINE STANDARDS COMPANY, LLC 221 US Route 1 Cumberland Foreside, ME 04110 |
| Contact | James Champlin |
| Correspondent | James Champlin MAINE STANDARDS COMPANY, LLC 221 US Route 1 Cumberland Foreside, ME 04110 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-14 |
| Decision Date | 2015-04-30 |
| Summary: | summary |