FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30
K Number: K981609
·
Decision Jun 3, 1998
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
66
Review Days
29
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Basic Information
- Device Name
- BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30
- K Number
- K981609
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Chemicals , Ltd.
- Date Received
- May 5, 1998
- Decision Date
- June 3, 1998
- Product Code
- CIG
- 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | FDA class 2 | Clinical Chemistry |
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