FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AU BICARBONATE REAGENT
K Number: K131546
·
Decision Oct 9, 2013
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
85
Applicant Total
7
Review Days
133
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
- AU BICARBONATE REAGENT
- K Number
- K131546
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter Ireland, Inc.
- Date Received
- May 29, 2013
- Decision Date
- October 9, 2013
- Product Code
- KHS
- 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 |
|---|---|---|---|
| KHS | Enzymatic, Carbon-Dioxide | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHS), ordered by most recent decision date.
Carbon Dioxide Reagent Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Liquid CO2-2 (LCO2-2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Beckman Coulter Ireland, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182651 | HbA1c Advanced | Jan 16, 2019 | Substantially Equivalent |
| K161508 | Ceruloplasmin | Jan 9, 2017 | Substantially Equivalent |
| K161297 | Beta-2-Microglobulin | Jun 7, 2016 | Substantially Equivalent |
| K142346 | Urine/CSF Albumin, Urine/CSF Albumin Calibrator | Oct 15, 2014 | Substantially Equivalent |
| K141388 | SYSTEM CALIBRATER | Jul 11, 2014 | Substantially Equivalent |
| K141374 | BICARBONATE CALIBRATOR | Jun 30, 2014 | Substantially Equivalent |