Blood Gas Analysis, Standards Controls
FDA 510(k) K813517 · United Diagnostics, Inc.
510(k) numberK813517
Submission
- Device name
- Blood Gas Analysis, Standards Controls
- Applicant
- United Diagnostics, Inc.
Mchenry, IL, US - Received
- December 16, 1981
- Decision date
- December 31, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1120
- Specialty
- Clinical Chemistry
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| 510(k) | Device | Decision |
|---|---|---|
| K884977 | Gas Trak PlusJJY · Traditional | 01/27/1989SE |
| K862278 | Gas-TrakJJY · Traditional | 08/04/1986SE |
| K844018 | Gas Trak Brand Co-Oximeter Controls 1,2 & 3JJY · Traditional | 11/27/1984SE |
| K843986 | Stat-Trak Plus Liquid Chemistry Controls 1,2 & 3JJY · Traditional | 11/27/1984SE |
| K831389 | Stat-Trak Liquid Electrolyte ControlJJR · Traditional | 08/10/1983SE |
| K831814 | Calibration Standard-HemoglobinKRZ · Traditional | 07/28/1983SE |
| K831813 | Co-Oximeter ControlKHG · Traditional | 07/28/1983SE |
| K831075 | Blood Gas & Flame Photometer Instru-CGC · Traditional | 06/22/1983SE |
| K820705 | Gas-Trak 2 Synthetic Blood Gas ControlJJS · Traditional | 04/01/1982SE |
| K810618 | Ampuled Flame Photometer StandardsJIS · Traditional | 03/31/1981SE |
Questions and answers
When was Blood Gas Analysis, Standards Controls cleared by the FDA?
Blood Gas Analysis, Standards Controls (K813517) received a 510(k) decision of Substantially Equivalent on December 31, 1981, 15 days after the submission was received.
What is the product code of K813517?
The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.