FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX
K Number: K901141
·
Decision Apr 9, 1990
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
31
Applicant Total
505
Review Days
27
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Basic Information
- Device Name
- PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX
- K Number
- K901141
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Baxter Healthcare Corp
- Date Received
- March 13, 1990
- Decision Date
- April 9, 1990
- Product Code
- JJC
- 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 |
|---|---|---|---|
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | FDA class 1 | Clinical Chemistry |
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