FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
RANDOX LIPOPROTEIN
K Number: K011568
·
Decision Sep 28, 2001
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
129
Applicant Total
116
Review Days
130
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
- RANDOX LIPOPROTEIN
- K Number
- K011568
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- May 21, 2001
- Decision Date
- September 28, 2001
- Product Code
- JIS
- 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 |
|---|---|---|---|
| JIS | Calibrator, Primary | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIS), ordered by most recent decision date.
DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION IRON CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Randox Laboratories, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| DEN240035 | ConcizuTrace ELISA | May 22, 2025 | Unknown |
| K230890 | ISE Electrodes | Sep 8, 2023 | Substantially Equivalent |
| K182042 | Randox Calcium (Ca) | Oct 23, 2018 | Substantially Equivalent |
| K162200 | Randox RX Daytona Plus Magnesium (MG) | Apr 28, 2017 | Substantially Equivalent |
| K152085 | Liquid CO2-2 (LCO2-2) | Feb 24, 2016 | Substantially Equivalent |
| K153435 | Direct HDL Cholesterol (HDL) | Jan 8, 2016 | Substantially Equivalent |
| K150654 | Cholesterol | Sep 29, 2015 | Substantially Equivalent |
| K131554 | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT | Jan 9, 2014 | Substantially Equivalent |
| K123977 | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | Nov 21, 2013 | Substantially Equivalent |
| K132156 | RANDOX CSF CONTROLS LEVELS 2 AND 3 | Oct 23, 2013 | Substantially Equivalent |