FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR
K Number: K813447
·
Decision Dec 31, 1981
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
129
Applicant Total
6
Review Days
30
Basic Information
- Device Name
- SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR
- K Number
- K813447
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- RNA MEDICAL CORP.
- Date Received
- December 1, 1981
- Decision Date
- December 31, 1981
- 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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Other Clearances by RNA MEDICAL CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K851362 | STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF | Jun 12, 1985 | Substantially Equivalent |
| K844589 | OSMOLARITY STANDARDS | Mar 1, 1985 | Substantially Equivalent |
| K842131 | FORMACLEAR- & MULTIPLE | Sep 10, 1984 | Substantially Equivalent |
| K842519 | BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 | Aug 17, 1984 | Substantially Equivalent |
| K830843 | BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU- | Apr 28, 1983 | Substantially Equivalent |