FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI
K Number: K123131
·
Decision Feb 8, 2013
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
45
Applicant Total
20
Review Days
127
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI
- K Number
- K123131
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1825
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tosoh Bioscience, Inc.
- Date Received
- October 4, 2012
- Decision Date
- February 8, 2013
- Product Code
- MRG
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRG | System, Test, Vitamin D | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MRG), ordered by most recent decision date.
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALFIS Vitamin D, ALFIS-3 Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access 25(OH) Vitamin D Total
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Elecsys Vitamin D total III
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Centaur Vitamin D Total (VitD)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAGLUMI 2000 25-OH Vitamin D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Tosoh Bioscience, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Oct 3, 2025 | Substantially Equivalent |
| K211199 | ST AIA-PACK BNP Assay | Nov 8, 2021 | Substantially Equivalent |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | Aug 5, 2021 | Substantially Equivalent |
| K160113 | ST AIA-PACK hsE2 Calibrator Set | Feb 17, 2016 | Substantially Equivalent |
| K153417 | ST AIA-PACK PROG III Calibrator Set | Dec 18, 2015 | Substantially Equivalent |
| K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set | Oct 26, 2015 | Substantially Equivalent |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | Jul 2, 2015 | Substantially Equivalent |
| K143296 | AIA-PACK C-Peptide Control Set | Dec 16, 2014 | Substantially Equivalent |
| K143144 | ST AIA-PACK PROG II Calibrator Set | Dec 3, 2014 | Substantially Equivalent |
| K140648 | ST AIA-PACK C-PEPTIDE II CALIBRATOR SET | Apr 10, 2014 | Substantially Equivalent |