Atlas FDA

KZQ

12 FDA 510(k) clearances · Product code

41 daysmedian time to decision
81 days90th percentile
12clearances measured

FDA profile

Official device name
Chromatography(Gas), Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2250
Medical specialty
Clinical Chemistry
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RecordFirmDate
8000 SERIES GAS CHROMATOGRAPHS (K872122)The Perkin-Elmer Corp.1987-06-17
VARIAN 3300 & 3400 GAS CHROMATOGRAPHS (K841891)Varian Assoc., Inc.1984-07-09
GAS CHROMATOGRAPH 5890A (K832962)Hewlett-Packard Co.1983-10-28
HS-100 HEADSPACE SAMPLING ACCESSORY (K831387)The Perkin-Elmer Corp.1983-08-24
SIGMA 300 GAS CHROMATROGRAPH (K830147)The Perkin-Elmer Corp.1983-02-07
SIGMA 2000 GAS CHROMATOGRAPH (K820283)The Perkin-Elmer Corp.1982-02-23
TRACE ANALYTICAL REDUCTION GAS ANALYZ (K820025)Trace Analytical1982-02-15
MODEL 5790 GAS CHROMATOGRAPH (K820071)Hewlett-Packard Co.1982-01-28
VISTA 44 GAS CHROMATOGRAPHY ANALYSIS (K801745)Varian Assoc., Inc.1980-08-20
5880 SERIES OF GAS CHROMATOGRAPHS (K791138)Hewlett-Packard Co.1979-07-24
DETECTOR, IR, MODEL GC-33 (K770639)Peokin-Elmer Corp.1977-06-24
GAS CHROMOTOGRAPHS, SIGMA 1,2,3,4,&10 (K770025)The Perkin-Elmer Corp.1977-02-16

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