The following data is part of a premarket notification filed by Maine Standards Co. with the FDA for Validate Vit D Calibration Verification/ Linearity Test Kit.
| Device ID | K113524 |
| 510k Number | K113524 |
| Device Name: | VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | MAINE STANDARDS CO. 765 ROOSEVELT TRAIL Windham, ME 04062 -5365 |
| Contact | Holly A Cressman |
| Correspondent | Holly A Cressman MAINE STANDARDS CO. 765 ROOSEVELT TRAIL Windham, ME 04062 -5365 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-29 |
| Decision Date | 2012-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859110005838 | K113524 | 000 |
| 00859110005852 | K113524 | 000 |
| 00859110005845 | K113524 | 000 |