Chemstrip 101 Urine Analyzer
FDA 510(k) K983510 · Boehringer Mannheim Corp.
510(k) numberK983510
Submission
- Device name
- Chemstrip 101 Urine Analyzer
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- October 7, 1998
- Decision date
- October 27, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K984326 | Elecys Ige AssayJHR · Traditional | 02/08/1999SE |
| K983047 | Accu-Chek HQ SystemLFR · Traditional | 02/05/1999SE |
| K984419 | Elecsys Ige CalcheckJJY · Traditional | 02/02/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K982949 | Elecsys Psa, Model 2010LTJ · Traditional | 10/27/1998SE |
Questions and answers
When was Chemstrip 101 Urine Analyzer cleared by the FDA?
Chemstrip 101 Urine Analyzer (K983510) received a 510(k) decision of Substantially Equivalent on October 27, 1998, 20 days after the submission was received.
What is the product code of K983510?
The FDA product code is KQO – Automated Urinalysis System, a Class I (low risk) device regulated under 21 CFR 862.2900.