Hemocue Albumin 201 Analyzing System
FDA 510(k) K053253 · Hemocue AB
510(k) numberK053253
Submission
- Device name
- Hemocue Albumin 201 Analyzing System
- Applicant
- Hemocue AB
Lake Forest, CA, US - Received
- November 21, 2005
- Decision date
- February 17, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KQO – Automated Urinalysis System
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2900
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141874 | Uriscan OptimaKQO · Traditional | Yd Diagnostics Corp. | 05/28/2015SE |
| K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube…KQO · Traditional | ACON Laboratories, Inc. | 05/11/2015SE |
| K140717 | Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis Cassette, Calibration…KQO · Traditional | Siemens Healthcare Diagnostics | 11/17/2014SE |
| K121456 | Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…KQO · Traditional | Arkray, Inc. | 02/01/2013SE |
| K102188 | Cybow Reader, Models 300 & 720KQO · Traditional | DFI Co., Ltd. | 08/09/2011SE |
| K101852 | Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitKQO · Traditional | Iris International Inc., A Division of Iris Iris I | 03/23/2011SE |
| K091472 | Uritest 50 and Uritest 500 Urine AnalyzerKQO · Traditional | Arj Medical, Inc. | 04/27/2010SE |
| K093555 | Cobas U411 Test SystemKQO · Traditional | Roche Diagnostics | 04/02/2010SE |
| K093098 | Aution Max Model AX-4030 Urinalysis SystemKQO · Special | Arkray, Inc. | 12/23/2009SE |
| K070929 | Acon U120 Urine Analyzer, Model U111-101KQO · Traditional | ACON Laboratories, Inc. | 07/30/2007SE |
More from ACON Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K201217 | HemoCue Hb 301 SystemGKR · Traditional | 08/04/2020SE |
| K181751 | HemoCue Hb 801 SystemGKR · Traditional | 02/01/2019SE |
| K071652 | Hemocue WBC SystemGKL · Traditional | 10/25/2007SE |
| K060765 | Hemocue Glucose 201 RT Analyzer MDL 120731, Hemocue Glucose 201 RT Microcurettes MDL…LFR · Traditional | 09/06/2006SE |
| K061047 | Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801GKR · Traditional | 06/08/2006SE |
| K041234 | Hemocue Hemoglobin 201DM Analyzing SystemGKR · Special | 06/10/2004SE |
| K041230 | Clinical Laboratory Analyzing SystemLFR · Special | 05/20/2004SE |
| K032203 | Hemocue Hemoglobin 201 + System Article 121704GKR · Special | 08/25/2003SE |
| K020935 | Hemocue Glucose 201 System, Article Number 120706CGA · Special | 04/03/2002SE |
| K962415 | Hemocue B-Glcose SystemLFR · Traditional | 10/15/1996SE |
Questions and answers
When was Hemocue Albumin 201 Analyzing System cleared by the FDA?
Hemocue Albumin 201 Analyzing System (K053253) received a 510(k) decision of Substantially Equivalent on February 17, 2006, 88 days after the submission was received.
What is the product code of K053253?
The FDA product code is KQO – Automated Urinalysis System, a Class I (low risk) device regulated under 21 CFR 862.2900.