The following data is part of a premarket notification filed by Horiba Abx with the FDA for General Chemistries On Abx Pentra 400 Clinical Chemistry Analyzer.
| Device ID | K060205 |
| 510k Number | K060205 |
| Device Name: | GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| 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 | CJE |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CIC |
| Subsequent Product Code | JGJ |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JIY |
| Subsequent Product Code | JJX |
| Subsequent Product Code | JJY |
| Subsequent Product Code | KHS |
| Subsequent Product Code | KNK |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-26 |
| Decision Date | 2006-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230007112 | K060205 | 000 |
| 03610230006863 | K060205 | 000 |
| 03610230005231 | K060205 | 000 |
| 03610230005088 | K060205 | 000 |
| 03610230005071 | K060205 | 000 |
| 03610230005002 | K060205 | 000 |
| 03610230004890 | K060205 | 000 |