FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
GLUCOSE-SL-C ASSAY, MODEL 257-30
K Number: K023739
·
Decision Jan 17, 2003
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
144
Applicant Total
66
Review Days
71
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Basic Information
- Device Name
- GLUCOSE-SL-C ASSAY, MODEL 257-30
- K Number
- K023739
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Chemicals , Ltd.
- Date Received
- November 7, 2002
- Decision Date
- January 17, 2003
- Product Code
- CFR
- 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 |
|---|---|---|---|
| CFR | Hexokinase, Glucose | FDA class 2 | Clinical Chemistry |
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