Atlas FDA

JJO

22 FDA 510(k) clearances · Product code

47 daysmedian time to decision
121 days90th percentile
22clearances measured

FDA profile

Official device name
Flame Emission Photometer For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2540
Medical specialty
Clinical Chemistry
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RecordFirmDate
FINNIGAN MAT INCOS 50 (K873603)Finnigan Corp.1987-09-22
OLYMPUS AU 5000 FLAME PHOTOMETER MODULE (K862148)Olympus Corp.1986-09-29
ELVI 655 FLAME PHOTOMETER (K843375)Logos Scientific, Inc.1985-05-20
LITHIUM REAGENT (K841847)Reagent Laboratory, Inc.1984-08-17
FLAME PHOTOMETERS (K834226)Dr. Bruno Lange GmbH1984-06-22
DAILY WASH SOLUTION 5 (K841421)Reagent Laboratory, Inc.1984-05-11
VOLUME TEST DYE 6 (K841422)Reagent Laboratory, Inc.1984-05-11
SUPPLIES FOR INSTRUMENTATION LAB FLAME (K840530)Shaban Mfg. Co.1984-03-30
SDI PREPAX DILUKIT 29-1000 (K840044)Scientific Distributors, Inc.1984-03-09
POTASSIUM SODIUM ANALYSIS PRODUCTS (K833535)Shaban Mfg. Co.1983-12-29
FLAME PHOTOMETER T281-T282-T283 (K832886)Texas Intl. Laboratories, Inc.1983-12-08
SHABAN #9868 TUBING KIT-9870 STYLET (K832937)Shaban Mfg. Co.1983-10-14
SHABAN #9858 ASPIRATOR ASSEMBLE #9862- (K832932)Shaban Mfg. Co.1983-10-14
SHABAN #9852 CHIMNEY-#9854 SCREEN & (K832931)Shaban Mfg. Co.1983-10-14
SHABAN #9850 PUMP WINDINGS-9860 FILTER (K832936)Shaban Mfg. Co.1983-10-14
IL 943 FLAME PHOTOMETER (K823480)Instrumentation Laboratory CO1983-01-09
CORNING 480 FLAME PHOTOMETER (K820631)Corning Medical & Scientific1982-04-01
MICROFLAME PHOTOMETER (K792087)Gilford Instrument Laboratories, Inc.1979-11-13
FLAME PHOTOMETER, MODEL 455 (K780650)Corning Medical & Scientific1978-05-26
FLAME PHOTOMETER, MODEL 435 (K780649)Corning Medical & Scientific1978-05-26
I.L. MODEL 643 FLAME PHOTOMETER (K771337)Instrumentation Laboratory CO1977-10-18
PROPANE, HIGH PURITY, INSTRUMENT GRADE (K770393)Hycel, Inc.1977-04-26

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