Exigent Diagnostics, Inc.
Culver City, CA, US
Exigent Diagnostics, Inc. appears in FDA device records in Culver City, CA. FDA records list 9 510(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
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Exigent Diagnostics, Inc. in 1998.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 9 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K982118 | CARESIDE ANALYZER | CHH | Substantially Equivalent | |
| K981899 | CARESIDE HDL-CHOLESTEROL | LBS | Substantially Equivalent | |
| K981183 | CARESIDE GLUCOSE | CGA | Substantially Equivalent | |
| K980043 | CARESIDE CREATININE | JFY | Substantially Equivalent | |
| K980056 | CARESIDE ANALYZER | JJF | Substantially Equivalent | |
| K980057 | CARESIDE BUN | CDQ | Substantially Equivalent | |
| K980042 | CARESIDE TOTAL PROTEIN | CEK | Substantially Equivalent | |
| K980041 | CARESIDE ALBUMIN | CIX | Substantially Equivalent | |
| K980055 | CARESIDE GLOBULIN | JGE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JFYEnzymatic Method, Creatinine
- CGAGlucose Oxidase, Glucose
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- JGETurbidimetric Method, Globulin
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain