510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KQOClass I

Automated Urinalysis System

21 CFR 862.2900 / Clinical Chemistry
FDA source (opens on fda.gov)

KQO is the FDA product code for Automated Urinalysis System, a class I device type, regulated under 21 CFR 862.2900. As of , FDA records hold 46 510(k) clearances under this code, the most recent dated , and 33 recalls.

Classification record

Product code
KQO
Device name
Automated Urinalysis System
Regulation
21 CFR 862.2900
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
46
Ingested recalls
33

Clearances, product code KQO

By decision year
46 clearances under product code KQO with a decision year between 1976 and 2015, 1996 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code KQO by decision year
YearClearances
19761
19771
19822
19831
19844
19871
19921
19934
19943
19952
19966
19971
19982
20011
20021
20032
20052
20061
20071
20091
20102
20112
20131
20141
20152

Applicants with the most clearances

Product code KQO
Applicants holding the most 510(k) clearances under product code KQO
ApplicantClearances
Boehringer Mannheim Corp.6
Miles Laboratories, Inc.6
Intl. Remote Imaging Systems4
Acon Laboratories, Inc.2
Arkray, Inc.2
Chimera Research & Chemical, Inc.2
Kulzer GmbH2
International Remote Imaging Systems2
Kyoto Daiichi Kagaku Co., Ltd.2
Solarcare Technologies Corp,Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 61 companies shown, in name order