LCH · Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
Clinical Chemistry · 21 CFR 862.1660 · Class 1
Overview
| Product Code | LCH |
|---|---|
| Device Name | Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical |
| Regulation | 21 CFR 862.1660 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Classification Rationale
Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K922386 | RNA MEDICAL TONOMETER | Bionostics, Inc. | Jun 26, 1992 | SESE |
| K904163 | CLINICAL BLOOD GAS MIXTURES | Norco, Inc. | Nov 1, 1990 | SESE |
| K900819 | BLOOD GAS CALIBRATION STANDARD | Cryogenic Rare Gas Laboratories, Inc. | Apr 25, 1990 | SESE |
| K862958 | AMR RESEARCH TONOMETER | Associated Medical Representatives | Nov 24, 1986 | SESE |
| K841089 | LINEAR CLOUD TONOMETER | Linear Tonometers, Inc. | May 22, 1984 | SESE |
| K802379 | HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER | American Instrument Co. | Oct 31, 1980 | SESE |
| K801599 | CORNING 184 BLOOD GAS TONOMETER | Corning Medical & Scientific | Aug 20, 1980 | SESE |
| K781417 | PRECISION GAS MIXER | Medicor USA , Ltd. | Sep 20, 1978 | SESE |
| K781386 | EBS 775 TONOMETER | Equilibrated Bio Systems, Inc. | Sep 14, 1978 | SESE |
Top Applicants
- American Instrument Co. — 1 clearance
- Associated Medical Representatives — 1 clearance
- Bionostics, Inc. — 1 clearance
- Corning Medical & Scientific — 1 clearance
- Cryogenic Rare Gas Laboratories, Inc. — 1 clearance
