Elan Holdings, Inc.
Brea, CA, US
Elan Holdings, Inc. appears in FDA device records in Brea, CA. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Elan Holdings, Inc. between 1999 and 2001. The busiest year on record is 1999, with 7. The most recent is 2001, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 7 |
| 2000 | 2 |
| 2001 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K013152 | ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS | LBS | Substantially Equivalent | |
| K012474 | ATAC PAK CPK REAGENT KIT | CGS | Substantially Equivalent | |
| K010488 | ATAC PAK AST REAGENT KIT | CIT | Substantially Equivalent | |
| K000958 | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS | CDQ | Substantially Equivalent | |
| K000900 | ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS | CHH | Substantially Equivalent | |
| K992844 | HICHEM ISE ELECTROLYTE BUFFER | JGS | Substantially Equivalent | |
| K992842 | HICHEM ISE ELECTROLYTE REFERENCE | JGS | Substantially Equivalent | |
| K992846 | HICHEM TOTAL PROTEIN REAGENT | CEK | Substantially Equivalent | |
| K992845 | HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT | JIX | Substantially Equivalent | |
| K992847 | HICHEM BUN REAGENT | LFP | Substantially Equivalent | |
| K991789 | ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS | LBR | Substantially Equivalent | |
| K991387 | ELAN ALKALINE PHOSPHATE REAGENT KIT | CJE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CEKBiuret (Colorimetric), Total Protein
- JIXCalibrator, Multi-Analyte Mixture
- LFPConductivity Rate, Urea Nitrogen
- JGSElectrode, Ion Specific, Sodium
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- LBRLdl & Vldl Precipitation, Hdl
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain