Submission Details
| 510(k) Number | K130765 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 20, 2013 |
| Decision Date | April 04, 2013 |
| Days to Decision | 15 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Abbreviated
ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II
Apr 2013
Decision
15d
Days
Class 2
Risk
About This 510(k) Submission
K130765 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on April 4, 2013, 15 days after receiving the submission on March 20, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
Similar Devices — JIX Calibrator, Multi-analyte Mixture
All 301
K161140 · Ortho-Clinical Diagnostics, Inc.
· May 2016
K153365 · Siemens Healthcare Diagnostics, Inc.
· Dec 2015
K151552 · Elitechgroup
· Jul 2015
K140790 · Siemens Healthcare Diagnostics
· Jun 2015
K141388 · Beckman Coulter Ireland, Inc.
· Jul 2014
K133330 · Roche Diagnostics
· Nov 2013
More from Elitechgroup
View all
K180559
· PGI · Oct 2018
K171401
· CIG · Jul 2017
K153644
· CFR · Sep 2016
K151113
· CJY · Jul 2015
K151552
· JIX · Jul 2015