The following data is part of a premarket notification filed by Maine Standards Co. with the FDA for Validate Gc1, Gc2, Gc3 And Gc4 Calibration Verification/linearity Test Set.
| Device ID | K091225 |
| 510k Number | K091225 |
| Device Name: | VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MAINE STANDARDS CO. 765 ROOSEVELT TRAIL Windham, ME 04062 -5365 |
| Contact | Holly Cressman |
| Correspondent | Holly Cressman 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 | 2009-04-27 |
| Decision Date | 2009-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859110005265 | K091225 | 000 |
| 00859110005449 | K091225 | 000 |
| 00859110005432 | K091225 | 000 |
| 00859110005425 | K091225 | 000 |
| 00859110005401 | K091225 | 000 |
| 00859110005395 | K091225 | 000 |
| 00859110005388 | K091225 | 000 |
| 00859110005371 | K091225 | 000 |
| 00859110005364 | K091225 | 000 |
| 00859110005357 | K091225 | 000 |
| 00859110005333 | K091225 | 000 |
| 00859110005326 | K091225 | 000 |
| 00859110005319 | K091225 | 000 |
| 00859110005302 | K091225 | 000 |
| 00859110005456 | K091225 | 000 |
| 00859110005463 | K091225 | 000 |
| 00859110005470 | K091225 | 000 |
| 00859110005258 | K091225 | 000 |
| 00859110005241 | K091225 | 000 |
| 00859110005234 | K091225 | 000 |
| 00859110005227 | K091225 | 000 |
| 00859110005210 | K091225 | 000 |
| 00859110005203 | K091225 | 000 |
| 00859110005197 | K091225 | 000 |
| 00859110005180 | K091225 | 000 |
| 00859110005418 | K091225 | 000 |
| 00859110005340 | K091225 | 000 |
| 00859110005289 | K091225 | 000 |
| 00859110005272 | K091225 | 000 |
| 00859110005487 | K091225 | 000 |
| 00859110005296 | K091225 | 000 |