FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOOD GAS ANALYSIS, STANDARDS CONTROLS
K Number: K813517
·
Decision Dec 31, 1981
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
187
Applicant Total
12
Review Days
15
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Basic Information
- Device Name
- BLOOD GAS ANALYSIS, STANDARDS CONTROLS
- K Number
- K813517
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1120
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- United Diagnostics, Inc.
- Date Received
- December 16, 1981
- Decision Date
- December 31, 1981
- Product Code
- CHL
- 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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | FDA class 2 | Clinical Chemistry |
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Other Clearances by United Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884977 | GAS TRAK PLUS | Jan 27, 1989 | Substantially Equivalent |
| K862278 | GAS-TRAK | Aug 4, 1986 | Substantially Equivalent |
| K843986 | STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 | Nov 27, 1984 | Substantially Equivalent |
| K844018 | GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 | Nov 27, 1984 | Substantially Equivalent |
| K831389 | STAT-TRAK LIQUID ELECTROLYTE CONTROL | Aug 10, 1983 | Substantially Equivalent |
| K831813 | CO-OXIMETER CONTROL | Jul 28, 1983 | Substantially Equivalent |
| K831814 | CALIBRATION STANDARD-HEMOGLOBIN | Jul 28, 1983 | Substantially Equivalent |
| K831075 | BLOOD GAS & FLAME PHOTOMETER INSTRU- | Jun 22, 1983 | Substantially Equivalent |
| K820705 | GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL | Apr 1, 1982 | Substantially Equivalent |
| K810618 | AMPULED FLAME PHOTOMETER STANDARDS | Mar 31, 1981 | Substantially Equivalent |