FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AG CHEMISTRY ANALYZER SYSTEM
K Number: K972409
·
Decision Aug 28, 1997
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
29
Applicant Total
1
Review Days
63
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Basic Information
- Device Name
- AG CHEMISTRY ANALYZER SYSTEM
- K Number
- K972409
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2140
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Landmark Scientific, Inc.
- Date Received
- June 26, 1997
- Decision Date
- August 28, 1997
- Product Code
- JJG
- 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 |
|---|---|---|---|
| JJG | Analyzer, Chemistry, Centrifugal, For Clinical Use | FDA class 1 | Clinical Chemistry |
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