Ua Perfect
FDA 510(k) K935408 · Chimera Research & Chemical, Inc.
510(k) numberK935408
Submission
- Device name
- Ua Perfect
- Applicant
- Chimera Research & Chemical, Inc.
Seminole, FL, US - Received
- November 9, 1993
- Decision date
- June 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K970087 | CR PerfectCGX · Traditional | 03/06/1997SE |
| K951877 | Automated Analysis Assay for Bilirubin in UrineKQO · Traditional | 05/14/1996SE |
| K953393 | Tox Perfect a TubeDMP · Traditional | 10/06/1995SE |
| K952501 | Tox Perfect B Tubes and ReagentsDPM · Traditional | 08/24/1995SE |
| K950142 | CR PerfectCGX · Traditional | 05/25/1995SE |
| K940768 | Ad PerfectIFT · Traditional | 02/17/1995SE |
Questions and answers
When was Ua Perfect cleared by the FDA?
Ua Perfect (K935408) received a 510(k) decision of Substantially Equivalent on June 13, 1994, 216 days after the submission was received.
What is the product code of K935408?
The FDA product code is KQO – Automated Urinalysis System, a Class I (low risk) device regulated under 21 CFR 862.2900.