FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AQUEOUS BLOOD GAS CONTROL
K Number: K833146
·
Decision Nov 28, 1983
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
66
Applicant Total
49
Review Days
74
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Basic Information
- Device Name
- AQUEOUS BLOOD GAS CONTROL
- K Number
- K833146
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bionostics, Inc.
- Date Received
- September 15, 1983
- Decision Date
- November 28, 1983
- 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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