Elan Diagnostics
Brea, CA, US
Elan Diagnostics appears in FDA device records in Brea, CA. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Elan Diagnostics between 1999 and 2003. The busiest year on record is 2003, with 8. The most recent is 2003, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 2 |
| 2002 | 2 |
| 2003 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K030003 | ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR | CIG | Substantially Equivalent | |
| K030014 | ATAC TOTAL BILIRUBIN REAGENT | CIG | Substantially Equivalent | |
| K030621 | ATAC CALIBRATOR | JIX | Substantially Equivalent | |
| K023105 | ATAC CALCIUM REAGENT AND ATAC CALIBRATOR | CIC | Substantially Equivalent | |
| K030010 | ATAC PAK MAGNESIUM REAGENT | JGJ | Substantially Equivalent | |
| K030015 | ATAC PAK PHOSPHORUS REAGENT | CEO | Substantially Equivalent | |
| K030006 | ATAC PAK ALBUMIN REAGENT | CIX | Substantially Equivalent | |
| K023407 | ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR | CGX | Substantially Equivalent | |
| K021385 | ATAC PAK BUN REAGENT | CDQ | Substantially Equivalent | |
| K020575 | ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS | MRR | Substantially Equivalent | |
| K002285 | ATAC PAK ALP REAGENT KIT | CJE | Substantially Equivalent | |
| K000556 | ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS | CFR | Substantially Equivalent | |
| K992029 | ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS | LBR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CIXBromcresol Green Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- CFRHexokinase, Glucose
- LBRLdl & Vldl Precipitation, Hdl
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- MRRSystem, Test, Low Density, Lipoprotein
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0404-03 | Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250 | Potential for reporting lower than actual HDL (cholesterol) results due to low QC Recovery | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain