FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
RANDOX CALCIUM
K Number: K000375
·
Decision Apr 5, 2000
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
98
Applicant Total
116
Review Days
58
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Basic Information
- Device Name
- RANDOX CALCIUM
- K Number
- K000375
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- February 7, 2000
- Decision Date
- April 5, 2000
- Product Code
- CIC
- 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 |
|---|---|---|---|
| CIC | Cresolphthalein Complexone, Calcium | FDA class 2 | Clinical Chemistry |
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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 |