The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Vitamin D Test System Nichols Advantage 25-hydroxyvitamin D.
| Device ID | K012367 |
| 510k Number | K012367 |
| Device Name: | VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D |
| Classification | Calibrator, Secondary |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33047 CALLE AVIADOR San Juan Capistrano, CA 92675 |
| Contact | Jimmy Wong |
| Correspondent | Jimmy Wong NICHOLS INSTITUTE DIAGNOSTICS 33047 CALLE AVIADOR San Juan Capistrano, CA 92675 |
| Product Code | JIT |
| Subsequent Product Code | JJX |
| Subsequent Product Code | MRG |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-26 |
| Decision Date | 2001-10-09 |
| Summary: | summary |