Company ยท US
Elitechgroup
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2018. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 3 |
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| JHW | U.V. Method, Cpk Isoenzymes | 2 |
| CFR | Hexokinase, Glucose | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CJY | Azo Dye, Calcium | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JFY | Enzymatic Method, Creatinine | 1 |
| JIT | Calibrator, Secondary | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 |
| KTB | Device, Iontophoresis, Specific Uses | 1 |
| PGI | Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 2018 | K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius Elitechgroup | PGI |
| Jul 27, 2018 | K180627 | Macroduct Advanced Model 3710 Elitechgroup, Inc. | KTB |
| Jul 11, 2017 | K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 Elitechgroup, FR | CIG |
| Sep 7, 2016 | K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITRO Elitechgroup, FR | CFR |
| Jul 22, 2015 | K151113 | ELITech Clinical Systems CALCIUM ARSENAZO Elitechgroup, FR | CJY |
| Jul 8, 2015 | K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II Elitechgroup, FR | JIX |
| Jul 18, 2014 | K141265 | ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT Elitechgroup | JHW |
| Jan 3, 2014 | K132399 | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL Elitechgroup | JFY |
| Apr 4, 2013 | K130765 | ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II Elitechgroup | JIX |
| Feb 15, 2013 | K122177 | ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL Elitechgroup | JIT |
| Oct 3, 2012 | K122858 | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II Elitechgroup | JFJ |
| Aug 22, 2012 | K122083 | ELITECH CLINICAL SYSTEMS CK NAC SL Elitechgroup | JHW |
| Dec 29, 2011 | K113269 | ELITTECH CLINICAL SYSTEMS ALP IFCC SL Elitechgroup | CJE |
| Nov 18, 2011 | K111960 | ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS Elitechgroup | KHS |
| Oct 7, 2011 | K110780 | ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II Elitechgroup | CIG |
| Sep 14, 2011 | K111996 | ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 Elitechgroup | JJY |
| Aug 30, 2011 | K112029 | ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 Elitechgroup | JIX |
| Jun 21, 2011 | K110830 | ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH Elitechgroup | CIX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||