Blood Gas Calibration Standard
FDA 510(k) K900819 · Cryogenic Rare Gas Laboratories, Inc.
510(k) numberK900819
Submission
- Device name
- Blood Gas Calibration Standard
- Applicant
- Cryogenic Rare Gas Laboratories, Inc.
Hanahan, SC, US - Received
- February 21, 1990
- Decision date
- April 25, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCH – Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LCH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K922386 | RNA Medical TonometerLCH · Traditional | Bionostics, Inc. | 06/26/1992SE |
| K904163 | Clinical Blood Gas MixturesLCH · Traditional | Norco, Inc. | 11/01/1990SE |
| K862958 | Amr Research TonometerLCH · Traditional | Associated Medical Representatives | 11/24/1986SE |
| K841089 | Linear Cloud TonometerLCH · Traditional | Linear Tonometers, Inc. | 05/22/1984SE |
| K802379 | Hem-O-Scan Oxygen Equil. Curve AnalyzerLCH · Traditional | American Instrument Co. | 10/31/1980SE |
| K801599 | Corning 184 Blood Gas TonometerLCH · Traditional | Corning Medical & Scientific | 08/20/1980SE |
| K781417 | Precision Gas MixerLCH · Traditional | Medicor USA , Ltd. | 09/20/1978SE |
| K781386 | Ebs 775 TonometerLCH · Traditional | Equilibrated Bio Systems, Inc. | 09/14/1978SE |
Questions and answers
When was Blood Gas Calibration Standard cleared by the FDA?
Blood Gas Calibration Standard (K900819) received a 510(k) decision of Substantially Equivalent on April 25, 1990, 63 days after the submission was received.
What is the product code of K900819?
The FDA product code is LCH – Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical, a Class I (low risk) device regulated under 21 CFR 862.1660.