The following data is part of a premarket notification filed by Maine Standards Co. with the FDA for Validate Tdm Calibration Verification Test Set, Model 126.
| Device ID | K033879 |
| 510k Number | K033879 |
| Device Name: | VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 |
| Classification | Calibrators, Drug Mixture |
| Applicant | MAINE STANDARDS CO. 765 ROOSEVELT TRAIL SUITE 9A Windham, ME 04062 -5365 |
| Contact | Christine Beach |
| Correspondent | Christine Beach MAINE STANDARDS CO. 765 ROOSEVELT TRAIL SUITE 9A Windham, ME 04062 -5365 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-15 |
| Decision Date | 2004-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859110005050 | K033879 | 000 |
| 00859110005043 | K033879 | 000 |
| 00859110005036 | K033879 | 000 |
| 00859110005029 | K033879 | 000 |
| 00859110005012 | K033879 | 000 |
| 00859110005005 | K033879 | 000 |