FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3
K Number: K092645
·
Decision Sep 5, 2009
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
45
Review Days
9
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
- FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3
- K Number
- K092645
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujirebio Diagnostics,Inc.
- Date Received
- August 27, 2009
- Decision Date
- September 5, 2009
- Product Code
- JJX
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJX), ordered by most recent decision date.
Beta-CrossLaps CalCheck 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Elecsys CYFRA 21-1 CalCheck 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Multichem A1c
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Audit MicroControls Linearity DROP LQ Blood Glucose
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIAISON CMV IgM Serum Control Set
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIAISON EBV IgM Serum Control Set
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Fujirebio Diagnostics,Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Dec 16, 2025 | Substantially Equivalent |
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | May 16, 2025 | Substantially Equivalent |
| DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) | May 4, 2022 | Unknown |
| K192524 | Lumipulse G CA15-3 | Sep 4, 2020 | Substantially Equivalent |
| K192380 | ST AIA-PACK BNP | Aug 24, 2020 | Substantially Equivalent |
| K200997 | Lumipulse G CA19-9-N | May 14, 2020 | Substantially Equivalent |
| K190702 | Lumipulse G whole PTH | Aug 30, 2019 | Substantially Equivalent |
| K172713 | Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set | Dec 10, 2017 | Substantially Equivalent |
| K171103 | Lumipulse G TSH-III Immunoreaction Cartridges | Jul 28, 2017 | Substantially Equivalent |
| K163546 | Lumipulse G Progesterone-N Calibrators | Jan 13, 2017 | Substantially Equivalent |