FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
K Number: K024182
·
Decision Mar 3, 2003
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
116
Applicant Total
3
Review Days
74
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Basic Information
- Device Name
- PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
- K Number
- K024182
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Precision Systems, Inc.
- Date Received
- December 19, 2002
- Decision Date
- March 3, 2003
- Product Code
- CDQ
- 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 |
|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
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