FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10
K Number: K980031
·
Decision Mar 3, 1998
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
35
Applicant Total
66
Review Days
57
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Basic Information
- Device Name
- ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10
- K Number
- K980031
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3030
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Chemicals , Ltd.
- Date Received
- January 5, 1998
- Decision Date
- March 3, 1998
- Product Code
- LDP
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| LDP | Colorimetry, Acetaminophen | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
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Other Clearances by Diagnostic Chemicals , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
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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 |