Elitechgroup
FDA 510(k) & PMA Approved Devices — 13 products
Total Devices13
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | PGI | 2018-10-29 | View |
| 510(k) | K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 | CIG | 2017-07-11 | View |
| 510(k) | K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II | CFR | 2016-09-07 | View |
| 510(k) | K130765 | ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II | JIX | 2013-04-04 | View |
| 510(k) | K122177 | ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL | JIT | 2013-02-15 | View |
| 510(k) | K122858 | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II | JFJ | 2012-10-03 | View |
| 510(k) | K122083 | ELITECH CLINICAL SYSTEMS CK NAC SL | JHW | 2012-08-22 | View |
| 510(k) | K113269 | ELITTECH CLINICAL SYSTEMS ALP IFCC SL | CJE | 2011-12-29 | View |
| 510(k) | K111960 | ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS | KHS | 2011-11-18 | View |
| 510(k) | K110780 | ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II | CIG | 2011-10-07 | View |
| 510(k) | K111996 | ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 | JJY | 2011-09-14 | View |
| 510(k) | K112029 | ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 | JIX | 2011-08-30 | View |
| 510(k) | K110830 | ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH | CIX | 2011-06-21 | View |
No matching devices.