FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
K Number: K042362
·
Decision Dec 27, 2004
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
85
Applicant Total
66
Review Days
118
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
- MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
- K Number
- K042362
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Chemicals , Ltd.
- Date Received
- August 31, 2004
- Decision Date
- December 27, 2004
- 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
AU BICARBONATE REAGENT
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
Other Clearances by Diagnostic Chemicals , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K070383 | ENZYMATIC CREATININE ASSAY (265 SERIES) | Jun 22, 2007 | Substantially Equivalent |
| K063208 | MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 | Jan 19, 2007 | Substantially Equivalent |
| K060139 | CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 | Apr 28, 2006 | Substantially Equivalent |
| K060140 | CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 | Apr 24, 2006 | Substantially Equivalent |
| K051757 | CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 | Nov 10, 2005 | Substantially Equivalent |
| K051191 | DCL MICROALBUMIN ASSAY, MODEL 252-20 | Jul 5, 2005 | Substantially Equivalent |
| K042330 | ACETAMINOPHEN-SL ASSAY | Jan 7, 2005 | Substantially Equivalent |
| K042329 | SALICYLATE-SL ASSAY | Dec 27, 2004 | Substantially Equivalent |
| K041928 | HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B | Nov 23, 2004 | Substantially Equivalent |
| K041926 | HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 | Nov 23, 2004 | Substantially Equivalent |