Company ยท US
Elan Holdings, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2001. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 |
| LFP | Conductivity Rate, Urea Nitrogen | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 9, 2001 | K013152 | ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS Elan Holdings, Inc. | LBS |
| Oct 3, 2001 | K012474 | ATAC PAK CPK REAGENT KIT Elan Holdings, Inc. | CGS |
| Apr 9, 2001 | K010488 | ATAC PAK AST REAGENT KIT Elan Holdings, Inc. | CIT |
| May 24, 2000 | K000958 | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS Elan Holdings, Inc. | CDQ |
| May 2, 2000 | K000900 | ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS Elan Holdings, Inc. | CHH |
| Nov 26, 1999 | K992844 | HICHEM ISE ELECTROLYTE BUFFER Elan Holdings, Inc. | JGS |
| Nov 26, 1999 | K992842 | HICHEM ISE ELECTROLYTE REFERENCE Elan Holdings, Inc. | JGS |
| Oct 18, 1999 | K992846 | HICHEM TOTAL PROTEIN REAGENT Elan Holdings, Inc. | CEK |
| Oct 18, 1999 | K992845 | HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT Elan Holdings, Inc. | JIX |
| Oct 14, 1999 | K992847 | HICHEM BUN REAGENT Elan Holdings, Inc. | LFP |
| Jul 9, 1999 | K991789 | ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS Elan Holdings, Inc. | LBR |
| May 19, 1999 | K991387 | ELAN ALKALINE PHOSPHATE REAGENT KIT Elan Holdings, Inc. | CJE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||