Atlas FDA

KIE

25 FDA 510(k) clearances · Product code

35 daysmedian time to decision
106 days90th percentile
25clearances measured

FDA profile

Official device name
Apparatus, High Pressure Liquid Chromatography
Device class
Class I (low risk)
Regulation
21 CFR 862.2260
Medical specialty
Clinical Chemistry
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RecordFirmDate
WATERS 515 HPLC PUMP (515) (K964588)Waters Corporation1996-11-29
PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP (K935666)The Perkin-Elmer Corp.1994-04-26
WATERS(TM) 996 PDA (K924347)Millipore Corp.1992-12-11
CHROMATOGRAPHY CLINICAL USE 75JQR (K914841)Millipore Corp.1991-12-10
EQUIPMENT/MATERIAL DECONTAMINATING KIT (K911299)Rohm and Haas Co.1991-04-08
THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR (K862506)Millipore Corp.1986-07-29
EMIT ANCILLARY REAGENTS (K844947)Syva Co.1985-06-28
SYVA SAMPLE SEAL (K844949)Syva Co.1985-02-15
DIFFERENTIAL REFRACTIVE INDEX DETECTOR (K800556)Hewlett-Packard Co.1980-03-25
DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM. (K800516)E.I. Dupont DE Nemours & Co., Inc.1980-03-19
LDC SPECTROMONITOR III (K800289)Laboratory Data Control1980-02-26
LDC CHROMATOGRAPHY ACCESSORY MODULE B (K800046)Laboratory Data Control1980-02-25
LDC CONSTAMETRIC III HIGHT PRESS. SOL. (K800048)Laboratory Data Control1980-01-29
LDC UVIII FIXED WAVELENGTH ULTRAVIOLET (K800047)Laboratory Data Control1980-01-21
SYSTEM CONTROLLER 720 SERIES (K791661)Waters Assoc., Inc.1979-09-24
CARTRIDGE HOLDER, RCM 100 (K782175)Waters Assoc., Inc.1979-02-15
SOLVENT DELIVERY SYSTEM (K790145)Waters Assoc., Inc.1979-02-15
DATA MODULE (K781915)Waters Assoc., Inc.1979-01-10
DETECTOR, MODEL 79875A, VARIABLE (K781771)Hewlett-Packard Co.1978-12-20
MODEL 5000, LIQUID CHROMATOGRAPHY (K781379)Varian Assoc., Inc.1978-09-14
AUTO. SAMPLING SYSTEM (K772364)Hewlett-Packard Co.1978-01-05
MONITOR, LIQ. CHROMATOGRAPHY LC-15 UV (K771156)The Perkin-Elmer Corp.1977-08-02
DETECTOR, UV, MOLEL GC-55 (K770638)Peokin-Elmer Corp.1977-06-24
L080 SERIES LIQUID CHROMATOGRAPH (K761351)Hewlett-Packard Co.1977-02-02
SERIES II LIQUID CHROMATOGRAPH (K761219)The Perkin-Elmer Corp.1977-02-01

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Every clearance here is in the API, with alerts when new ones post.