The following data is part of a premarket notification filed by Horiba Abx with the FDA for Hepatic Enzymes On Abx Pentra 400 Clinical Chemistry Analyzer.
| Device ID | K060318 |
| 510k Number | K060318 |
| Device Name: | HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Contact | Tim Lawton |
| Correspondent | Tim Lawton HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Product Code | CIT |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-08 |
| Decision Date | 2006-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230004920 | K060318 | 000 |