Atlas FDA

KZR

15 FDA 510(k) clearances · Product code

45 daysmedian time to decision
60 days90th percentile
15clearances measured

FDA profile

Official device name
Chromatography (Liquid, Gel), Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2260
Medical specialty
Clinical Chemistry
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RecordFirmDate
2487 DUAL WAVELENGTH ABSORBANCE DETECTOR (K973074)Waters Corporation1997-10-06
USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 (K931227)U.S. Drug Testing, Inc.1993-05-06
COLUMNS LIQUID CHROMATOGRAPHY DPM (K905538)Millpore Corp.1991-01-25
SYVA SOLID PHASE COLUMNS SYSTEM II (K861392)Syva Co.1986-06-13
SERIES 410 LC PUMP (K860197)The Perkin-Elmer Corp.1986-03-17
VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM (K851945)Varian Assoc., Inc.1985-05-24
LIQUID CHROMATOGRAPH 400 (K843568)The Perkin-Elmer Corp.1984-11-20
VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY (K841890)Varian Assoc., Inc.1984-06-14
LIQUID CHROMATOGRAPHIC DETECTOR LC-95 (K840977)The Perkin-Elmer Corp.1984-04-19
CHROM-PREP (K832201)Hamilton Co.1983-08-16
VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS (K802725)Varian Assoc., Inc.1980-12-11
LIQUID CHROMATOGRAPH MODEL 850 (K780944)E.I. Dupont DE Nemours & Co., Inc.1978-07-27
LIQUID CHROMATOGRAPH MODEL 860 (K780945)E.I. Dupont DE Nemours & Co., Inc.1978-07-27
LC-65T DETECTOR AND OVEN (K770255)The Perkin-Elmer Corp.1977-02-25
CHROMATOGRAPH, SERIES 3, LIQUID (K770254)The Perkin-Elmer Corp.1977-02-24

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