FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PH/BLOOD GAS CONTROL (ABC)
K Number: K811143
·
Decision May 13, 1981
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
66
Applicant Total
300
Review Days
16
Basic Information
- Device Name
- PH/BLOOD GAS CONTROL (ABC)
- K Number
- K811143
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- INSTRUMENTATION LABORATORY CO.
- Date Received
- April 27, 1981
- Decision Date
- May 13, 1981
- Product Code
- JJS
- 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 |
|---|---|---|---|
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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