Panels › Clinical Chemistry › Product code KQO · Class 1
Automated Urinalysis System
Regulation 862.2900
0510(k)s in 12 months (46 all time)
2recalls in 12 months (35 all time)
24recalls that name a 510(k)
Top companies in KQO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Beckman Coulter, Inc. IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997;
IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684;
IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B4899 Open, Classified |
KQO | K022774 K210127 +1 |
| Oct 15, 2026 | Beckman Coulter, Inc. DxU 840m Iris, REF: C76947;
DxU 850m Iris, REF: C49513 Open, Classified |
KQO | K022774 K210127 +1 |
| May 17, 2023 | Beckman Coulter, Inc. UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis Open, Classified |
KQO | K022774 K093861 +1 |
| May 17, 2023 | Beckman Coulter, Inc. DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis Open, Classified |
KQO | K022774 K093861 +1 |
| May 17, 2023 | Beckman Coulter, Inc. DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis Open, Classified |
KQO | K022774 K093861 +1 |
| May 17, 2023 | Beckman Coulter, Inc. iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Se Open, Classified |
KQO | K022774 K093861 +1 |
| Oct 18, 2021 | Roche Diagnostics Operations, Inc. Cobas u 601 urinalysis test system, Catalog number 06334601001
The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyz Terminated |
KQO | K183432 |
| May 9, 2020 | Beckman Coulter Inc. iQ200 Series Urine Microscopy Analyzer- All part numbers Terminated |
KQO | K022774 |
| May 9, 2020 | Beckman Coulter Inc. iChemVELOCITY Urine Chemistry System- Terminated |
KQO | K101852 |
| Feb 17, 2020 | Beckman Coulter, Inc. iChemVELOCITY Strips, Catalog 800-7212 Terminated |
KQO | K101852 |
| Jan 21, 2020 | Sysmex America, Inc. Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers. Terminated |
KQO | None listed |
| Nov 7, 2019 | Beckman Coulter Inc. iChem VELOCITY Urine Chemistry Analyzer Terminated |
KQO | K101852 |
| Oct 28, 2019 | Beckman Coulter Inc. iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Terminated |
KQO | K101852 |
| May 3, 2019 | Arkray Factory USA, Inc. AUTION HYBRID AU-4050 Terminated |
KQO | K121456 |
| Oct 18, 2018 | Beckman Coulter Inc. iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany. Terminated |
KQO | K101852 |
| Apr 27, 2018 | Beckman Coulter Inc. iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001.
The iChemVELOCITY automated urine chem Terminated |
KQO | K101852 |
| Mar 2, 2018 | Beckman Coulter Inc. BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800-
7106, 800-3049, 800-3050, 800-3079, 800-3080,
800-7190, 800-7713, 800-7714, 800-77 Terminated |
KQO | K101852 |
| Mar 2, 2018 | Beckman Coulter Inc. BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370 Terminated |
KQO | K022774 |
| Nov 10, 2017 | Beckman Coulter Inc. iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800 Terminated |
KQO | K022774 |
| Mar 1, 2017 | Beckman Coulter Inc. iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061.
The iChem Velocity automated u Terminated |
KQO | K101852 |
| Jan 13, 2016 | Beckman Coulter Inc. iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720
iChem VELOCITY Urine Chemistry Strip Terminated |
KQO | K101852 |
| Aug 21, 2015 | Iris Diagnostics iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to a Terminated |
KQO | K101852 |
| May 4, 2014 | Siemens Healthcare Diagnostics Inc CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946. Terminated |
KQO | K091216 |
| Oct 25, 2013 | HemoCue AB HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden
The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, th Terminated |
KQO | K053253 |
| Jan 11, 2012 | Teco Diagnostics Urine Reagent Strips (URS) 11 Parameters
URS-11-100G-001
510(K) number: K970250
Devise Listing number: D072377
Each Device consists of 100 strips of Urine Reagent Strips 11 parameters packed with a Terminated |
KQO | None listed |
| Jan 11, 2012 | Teco Diagnostics Urine Reagent Strips (URS) 10 Parameters
URS-l0-100W
510(K) number: K970250
Devise Listing number: D072377
Each device consists of 100 strips of Urine Reagent Strips 10 parameters
packed with a desi Terminated |
KQO | None listed |
| Dec 9, 2010 | Teco Diagnostics NDC, Inc. Pro Advantage Urine Analyzer, Catalog Number: Pro Advantage Urine Analyzer
The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This Terminated |
KQO | None listed |
| Dec 9, 2010 | Teco Diagnostics McKesson Medical Surgical 107-101 Urine Analyzer, Catalog Number: 107-101
The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device ha Terminated |
KQO | None listed |
| Dec 9, 2010 | Teco Diagnostics Immunostics, Inc. Detector UriStrip Urine Analyzer, Catalog Number: Detector UriStrip Urine Analyzer
The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistr Terminated |
KQO | None listed |
| Dec 9, 2010 | Teco Diagnostics Henry Schein, Inc. OneStep Pro Urine Analyzer, Catalog Number: OneStep Pro Urine Analyzer
The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. Terminated |
KQO | None listed |
| Dec 9, 2010 | Teco Diagnostics Cole Taylor Marketing, Inc. CT-101 Urine Analyzer, Catalog Number: CT-101
The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device ha Terminated |
KQO | None listed |
| Dec 9, 2010 | Teco Diagnostics Cliawaived, Inc. CLIA-101 Urine Analyzer, Catalog Number: CLIA-101
The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been Terminated |
KQO | None listed |
| Dec 9, 2010 | Teco Diagnostics Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101
The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has be Terminated |
KQO | None listed |
| Feb 4, 2006 | Teco Diagnostics Uritek TC-101Urine Analyzer, catalog number TC-101 Terminated |
KQO | None listed |
| Jul 20, 2004 | Bayer Healthcare LLC Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed). Terminated |
KQO | K960546 |
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