510(k) K102188
- Device
- CYBOW READER, MODELS 300 & 720
- Applicant
- DFI CO., LTD.
- 510(k) number
- K102188
- Product code
- KQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-08-09
- Date received
- 2010-08-03
- Regulation
- 862.2900
- Classification name
- Automated Urinalysis System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- YANG HO-DONG
- Address
- #821 Samil Plz., 837-26 Yeuksam-Dong Gangnam-Gu, Seoul KR 135-937 135-937
FDA Registration Numbers#
- 3038206980
- 3003422726
- 3013188547
- 3009238284
- 3014150341
- 9615507
- 3042471840
- 3006198300
- 3009448641
- 3013660430
- 3027645317
- 9680746
- 1649661
- 9610633
- 3008987086
- 9710094
- 3027225088
- 1616487
- 1417592
- 3008058135
- 9611444
- 3018771894
- 3034731501
- 3043088937
- 4580
- 3007301207
- 2029372
- 9610126
- 3043226252
- 3010564249
- 3043127699
- 3003795116
- 1036362
- 3043138885
- 3010324880
- 1181121
- 3010891909
- 3008517993
- 1832816
- 3005360469
- 3015341499
- 3006621318
- 3002637618
- 1832216
- 3033509895
- 3013679502
- 3015921024
- 3024463179
- 3006479639
- 3006979678
- 3012494290
- 1061932
- 2122870
- 3020704087
- 3003917514
- 3004875840
- 3031915160
- 3038188172
- 1000369487
- 2030633
- 3005146144
- 2531491
- 3003741796
- 2432235
Source Documents#
Other 510(k) Records For Product Code KQO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K141874 | URISCAN OPTIMA | Yd Diagnostics Corp. | 2015-05-28 |
| K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control | ACON Laboratories, Inc. | 2015-05-11 |
| K140717 | CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT | Siemens Healthcare Diagnostics | 2014-11-17 |
| K121456 | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL | Arkray, Inc. | 2013-02-01 |
| K101852 | CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT | Iris International Inc., A Division of Iris Iris I | 2011-03-23 |
| K091472 | URITEST 50 AND URITEST 500 URINE ANALYZER | Arj Medical, Inc. | 2010-04-27 |
| K093555 | COBAS U411 TEST SYSTEM | Roche Diagnostics | 2010-04-02 |
| K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM | Arkray, Inc. | 2009-12-23 |
| K070929 | ACON U120 URINE ANALYZER, MODEL U111-101 | ACON Laboratories, Inc. | 2007-07-30 |
| K053253 | HEMOCUE ALBUMIN 201 ANALYZING SYSTEM | Hemocue AB | 2006-02-17 |
| K051526 | URITEK-720+ URINE ANALYZER | Teco Diagnostics | 2005-08-16 |
| K042421 | URITEK 151 URINE ANALYZER, MODEL TC-151 | Teco Diagnostics | 2005-05-09 |
| K031947 | BAYER CLINITEK STATUS ANALYZER | Bayer Healthcare, LLC | 2003-12-19 |
| K030600 | AUTION JET AJ-4270 URINE ANALYZER | International Remote Imaging Systems | 2003-07-11 |
| K013783 | AUTION MAX AX-4280 URINALYSIS SYSTEM | International Remote Imaging Systems | 2002-01-18 |
Legacy Summary#
summary
FDA Review#
Decision Summary