JJO · Flame Emission Photometer For Clinical Use
Clinical Chemistry · 21 CFR 862.2540 · Class 1
Overview
| Product Code | JJO |
|---|---|
| Device Name | Flame Emission Photometer For Clinical Use |
| Regulation | 21 CFR 862.2540 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A flame emission photometer for clinical use is a device intended to measure the concentration of sodium, potassium, lithium, and other metal ions in body fluids. Abnormal variations in the concentration of these substances in the body are indicative of certain disorders (e.g., electrolyte imbalance and heavy metal intoxication) and are, therefore, useful in diagnosis and treatment of those disorders.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 22)
Showing 20 most recent of 22 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K873603 | FINNIGAN MAT INCOS 50 | Finnigan Corp. | Sep 22, 1987 | SESE |
| K862148 | OLYMPUS AU 5000 FLAME PHOTOMETER MODULE | Olympus Corp. | Sep 29, 1986 | SESE |
| K843375 | ELVI 655 FLAME PHOTOMETER | Logos Scientific, Inc. | May 20, 1985 | SESE |
| K841847 | LITHIUM REAGENT | Reagent Laboratory, Inc. | Aug 17, 1984 | SESE |
| K834226 | FLAME PHOTOMETERS | Dr. Bruno Lange GmbH | Jun 22, 1984 | SESE |
| K841422 | VOLUME TEST DYE 6 | Reagent Laboratory, Inc. | May 11, 1984 | SESE |
| K841421 | DAILY WASH SOLUTION 5 | Reagent Laboratory, Inc. | May 11, 1984 | SESE |
| K840530 | SUPPLIES FOR INSTRUMENTATION LAB FLAME | Shaban Mfg. Co. | Mar 30, 1984 | SESE |
| K840044 | SDI PREPAX DILUKIT 29-1000 | Scientific Distributors, Inc. | Mar 9, 1984 | SESE |
| K833535 | POTASSIUM SODIUM ANALYSIS PRODUCTS | Shaban Mfg. Co. | Dec 29, 1983 | SESE |
| K832886 | FLAME PHOTOMETER T281-T282-T283 | Texas Intl. Laboratories, Inc. | Dec 8, 1983 | SESE |
| K832937 | SHABAN #9868 TUBING KIT-9870 STYLET | Shaban Mfg. Co. | Oct 14, 1983 | SESE |
| K832936 | SHABAN #9850 PUMP WINDINGS-9860 FILTER | Shaban Mfg. Co. | Oct 14, 1983 | SESE |
| K832932 | SHABAN #9858 ASPIRATOR ASSEMBLE #9862- | Shaban Mfg. Co. | Oct 14, 1983 | SESE |
| K832931 | SHABAN #9852 CHIMNEY-#9854 SCREEN & | Shaban Mfg. Co. | Oct 14, 1983 | SESE |
| K823480 | IL 943 FLAME PHOTOMETER | Instrumentation Laboratory CO | Jan 9, 1983 | SESE |
| K820631 | CORNING 480 FLAME PHOTOMETER | Corning Medical & Scientific | Apr 1, 1982 | SESE |
| K792087 | MICROFLAME PHOTOMETER | Gilford Instrument Laboratories, Inc. | Nov 13, 1979 | SESE |
| K780650 | FLAME PHOTOMETER, MODEL 455 | Corning Medical & Scientific | May 26, 1978 | SESE |
| K780649 | FLAME PHOTOMETER, MODEL 435 | Corning Medical & Scientific | May 26, 1978 | SESE |
Top Applicants
- Shaban Mfg. Co. — 6 clearances
- Corning Medical & Scientific — 3 clearances
- Reagent Laboratory, Inc. — 3 clearances
- Instrumentation Laboratory CO — 2 clearances
- Dr. Bruno Lange GmbH — 1 clearance
