FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
K Number: K033921
·
Decision Mar 10, 2004
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
29
Applicant Total
66
Review Days
83
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Basic Information
- Device Name
- AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
- K Number
- K033921
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1065
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Chemicals , Ltd.
- Date Received
- December 18, 2003
- Decision Date
- March 10, 2004
- Product Code
- JIF
- 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 |
|---|---|---|---|
| JIF | Enzymatic Method, Ammonia | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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| 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 |
| K042362 | MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 | Dec 27, 2004 | Substantially Equivalent |
| K041928 | HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B | Nov 23, 2004 | Substantially Equivalent |