FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOOD GAS MIXTURE
K Number: K954546
·
Decision Dec 28, 1995
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
129
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- BLOOD GAS MIXTURE
- K Number
- K954546
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Liquid Technology Corp.
- Date Received
- September 29, 1995
- Decision Date
- December 28, 1995
- Product Code
- JIS
- 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 |
|---|---|---|---|
| JIS | Calibrator, Primary | FDA class 2 | Clinical Chemistry |
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