The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect 25-oh Vitamin D 5p02, Architect 25-oh Vitamin D 5p02 Calibrators, Architect 25-oh Vitamin D 5p02 Controls.
| Device ID | K153375 |
| 510k Number | K153375 |
| Device Name: | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls |
| Classification | System, Test, Vitamin D |
| Applicant | ABBOTT LABORATORIES DEPT 093E, BLDG. AP 8 100 ABBOTT PARK ROAD Abbott Park, IL 60064 -6038 |
| Contact | Laura Yelvigi Joglekar |
| Correspondent | Judith R Wallach ABBOTT LABORATORIES DEPT 09AA, BLDG. AP8-1 100 ABBOTT PARK ROAD Abbott Park, IL 60064 -6038 |
| Product Code | MRG |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-23 |
| Decision Date | 2016-08-12 |
| Summary: | summary |