The following data is part of a premarket notification filed by Horiba Abx with the FDA for Cardiac Markers On Abx Pentra 400 Clinical Chemistry Analyzer.
| Device ID | K062737 |
| 510k Number | K062737 |
| Device Name: | CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER |
| Classification | Nad Reduction/nadh Oxidation, Cpk 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 | CGS |
| Subsequent Product Code | DDR |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JIY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-13 |
| Decision Date | 2007-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230006948 | K062737 | 000 |