The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra 400 Clinical Chemistry Analyzer (option: I.s.e. Module).
| Device ID | K052007 |
| 510k Number | K052007 |
| Device Name: | ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) |
| Classification | Hexokinase, Glucose |
| 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 | CFR |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-25 |
| Decision Date | 2005-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230006757 | K052007 | 000 |
| 03610230005217 | K052007 | 000 |
| 03610230005880 | K052007 | 000 |
| 03610230005897 | K052007 | 000 |
| 03610230005903 | K052007 | 000 |
| 03610230006528 | K052007 | 000 |
| 03610230006535 | K052007 | 000 |
| 03610230006542 | K052007 | 000 |
| 03610230006559 | K052007 | 000 |
| 03610230006740 | K052007 | 000 |
| 03610230005200 | K052007 | 000 |