FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
K Number: K131307
·
Decision Jan 24, 2014
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
152
Review Days
262
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
- ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
- K Number
- K131307
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date Received
- May 7, 2013
- Decision Date
- January 24, 2014
- Product Code
- LCP
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCP), ordered by most recent decision date.
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Q-Pad Test System
FDA 510(k)
FDA Class 2
·Hematology
Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Aina HbA1c Monitoring System 2
FDA 510(k)
FDA Class 2
·Hematology
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
FDA 510(k)
FDA Class 2
·Hematology
OneDraw A1C Test System
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Siemens Healthcare Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | Feb 27, 2026 | Substantially Equivalent |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Feb 6, 2026 | Substantially Equivalent |
| K251630 | Atellica IM Total PSA II (tPSAII) | Jan 5, 2026 | Substantially Equivalent |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Dec 4, 2025 | Substantially Equivalent |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Oct 17, 2025 | Substantially Equivalent |
| K242981 | Atellica IM Thyroglobulin (Tg) | Jun 20, 2025 | Substantially Equivalent |
| K242685 | Atellica® CH Creatinine_3 (Crea3) | Dec 4, 2024 | Substantially Equivalent |
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | Jul 26, 2024 | Substantially Equivalent |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | Jul 25, 2024 | Substantially Equivalent |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Apr 4, 2024 | Substantially Equivalent |