CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM
FDA 510(k) clearance K932674 · decided 1993-08-19
Clearance details
- K-number
- K932674
- Device name
- CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM
- Applicant
- Miles Inc., Dental Products
- Decision
- Substantially Equivalent
- Date received
- 1993-06-02
- Decision date
- 1993-08-19
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- KQO
- Device class
- 1
- Regulation number
- 862.2900
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- South Bend, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| URISCAN OPTIMA (K141874) | Yd Diagnostics Corp. | 2015-05-28 |
| Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control (K142543) | ACON Laboratories, Inc. | 2015-05-11 |
| CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT (K140717) | Siemens Healthcare Diagnostics | 2014-11-17 |
| AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL (K121456) | Arkray, Inc. | 2013-02-01 |
| CYBOW READER, MODELS 300 & 720 (K102188) | DFI Co., Ltd. | 2011-08-09 |
| CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT (K101852) | Iris International Inc., A Division of Iris Iris I | 2011-03-23 |
| URITEST 50 AND URITEST 500 URINE ANALYZER (K091472) | Arj Medical, Inc. | 2010-04-27 |
| COBAS U411 TEST SYSTEM (K093555) | Roche Diagnostics | 2010-04-02 |
| AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (K093098) | Arkray, Inc. | 2009-12-23 |
| ACON U120 URINE ANALYZER, MODEL U111-101 (K070929) | ACON Laboratories, Inc. | 2007-07-30 |
| HEMOCUE ALBUMIN 201 ANALYZING SYSTEM (K053253) | Hemocue AB | 2006-02-17 |
| URITEK-720+ URINE ANALYZER (K051526) | Teco Diagnostics | 2005-08-16 |
Recalls involving this device
No recalls on record reference this clearance.