Product Code: JJO FDA class 1 21 CFR 862.2540

Flame Emission Photometer For Clinical Use

Clinical Chemistry

This device is a flame emission photometer used in clinical laboratories to measure the concentration of specific metal ions, most commonly sodium and potassium, in biological specimens by detecting characteristic light emitted when the sample is introduced into a flame. It is classified as FDA Class 1, the lowest risk category, requiring only general controls without a premarket submission. The product code is JJO, regulated under 21 CFR 862.2540, within the Clinical Chemistry medical specialty.

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Basic Information

Product Code: JJO
Device Class: FDA class 1
Regulation Number: 862.2540
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 22 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K873603	FINNIGAN MAT INCOS 50	Sep 22, 1987	Substantially Equivalent	Finnigan Corp.
K862148	OLYMPUS AU 5000 FLAME PHOTOMETER MODULE	Sep 29, 1986	Substantially Equivalent	Olympus Corp.
K843375	ELVI 655 FLAME PHOTOMETER	May 20, 1985	Substantially Equivalent	Logos Scientific, Inc.
K841847	LITHIUM REAGENT	Aug 17, 1984	Substantially Equivalent	Reagent Laboratory, Inc.
K834226	FLAME PHOTOMETERS	Jun 22, 1984	Substantially Equivalent	Dr. Bruno Lange GmbH
K841422	VOLUME TEST DYE 6	May 11, 1984	Substantially Equivalent	Reagent Laboratory, Inc.
K841421	DAILY WASH SOLUTION 5	May 11, 1984	Substantially Equivalent	Reagent Laboratory, Inc.
K840530	SUPPLIES FOR INSTRUMENTATION LAB FLAME	Mar 30, 1984	Substantially Equivalent	Shaban Mfg. Co.
K840044	SDI PREPAX DILUKIT 29-1000	Mar 09, 1984	Substantially Equivalent	Scientific Distributors, Inc.
K833535	POTASSIUM SODIUM ANALYSIS PRODUCTS	Dec 29, 1983	Substantially Equivalent	Shaban Mfg. Co.
K832886	FLAME PHOTOMETER T281-T282-T283	Dec 08, 1983	Substantially Equivalent	Texas Intl. Laboratories, Inc.
K832937	SHABAN #9868 TUBING KIT-9870 STYLET	Oct 14, 1983	Substantially Equivalent	Shaban Mfg. Co.
K832936	SHABAN #9850 PUMP WINDINGS-9860 FILTER	Oct 14, 1983	Substantially Equivalent	Shaban Mfg. Co.
K832932	SHABAN #9858 ASPIRATOR ASSEMBLE #9862-	Oct 14, 1983	Substantially Equivalent	Shaban Mfg. Co.
K832931	SHABAN #9852 CHIMNEY-#9854 SCREEN &	Oct 14, 1983	Substantially Equivalent	Shaban Mfg. Co.
K823480	IL 943 FLAME PHOTOMETER	Jan 09, 1983	Substantially Equivalent	Instrumentation Laboratory CO
K820631	CORNING 480 FLAME PHOTOMETER	Apr 01, 1982	Substantially Equivalent	Corning Medical & Scientific
K792087	MICROFLAME PHOTOMETER	Nov 13, 1979	Substantially Equivalent	Gilford Instrument Laboratories, Inc.
K780650	FLAME PHOTOMETER, MODEL 455	May 26, 1978	Substantially Equivalent	Corning Medical & Scientific
K780649	FLAME PHOTOMETER, MODEL 435	May 26, 1978	Substantially Equivalent	Corning Medical & Scientific
K771337	I.L. MODEL 643 FLAME PHOTOMETER	Oct 18, 1977	Substantially Equivalent	Instrumentation Laboratory CO
K770393	PROPANE, HIGH PURITY, INSTRUMENT GRADE	Apr 26, 1977	Substantially Equivalent	Hycel, Inc.