The following data is part of a premarket notification filed by Maine Standards Co. with the FDA for Validate Urine Chemistry Calibration Verification Test Sets.
| Device ID | K050504 |
| 510k Number | K050504 |
| Device Name: | VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MAINE STANDARDS CO. 765 ROOSEVELT TRAIL Windham, ME 04062 -5365 |
| Contact | Chirstine Beach |
| Correspondent | Chirstine Beach 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 | 2005-02-28 |
| Decision Date | 2005-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859110005968 | K050504 | 000 |
| 00850011135013 | K050504 | 000 |
| 00850011135020 | K050504 | 000 |
| 00850011135037 | K050504 | 000 |
| 00850011135051 | K050504 | 000 |
| 00850011135068 | K050504 | 000 |
| 00850011135075 | K050504 | 000 |
| 00850011135082 | K050504 | 000 |
| 00850011135112 | K050504 | 000 |
| 00850011135129 | K050504 | 000 |
| 00850011135136 | K050504 | 000 |
| 00850011135143 | K050504 | 000 |
| 00850011135150 | K050504 | 000 |
| 00850011135167 | K050504 | 000 |
| 00859110005975 | K050504 | 000 |
| 00859110005982 | K050504 | 000 |
| 00850011135044 | K050504 | 000 |
| 00850011135105 | K050504 | 000 |
| 00850011135006 | K050504 | 000 |