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 |