The following data is part of a premarket notification filed by Maine Standards Company, Llc with the FDA for Validate (r) Gc3 Calibration Verification / Linearity Test Kit.
| Device ID | K110880 |
| 510k Number | K110880 |
| Device Name: | VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MAINE STANDARDS COMPANY, LLC 765 ROOSEVELT TRAIL Windham, ME 04062 |
| Contact | Holly Cressman |
| Correspondent | Holly Cressman MAINE STANDARDS COMPANY, LLC 765 ROOSEVELT TRAIL Windham, ME 04062 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-30 |
| Decision Date | 2011-07-05 |
| Summary: | summary |