FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
K Number: K972609
·
Decision Aug 6, 1997
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
18
Applicant Total
319
Review Days
26
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Basic Information
- Device Name
- VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
- K Number
- K972609
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3450
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad
- Date Received
- July 11, 1997
- Decision Date
- August 6, 1997
- Product Code
- LCQ
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| LCQ | Fluorescent Immunoassay Gentamicin | FDA class 2 | Clinical Toxicology |
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