The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Micros Crp 200, Option Im.
| Device ID | K053308 |
| 510k Number | K053308 |
| Device Name: | ABX MICROS CRP 200, OPTION IM |
| Classification | Counter, Differential Cell |
| 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 | GKZ |
| Subsequent Product Code | DCK |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| Subsequent Product Code | JQP |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-28 |
| Decision Date | 2005-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230004777 | K053308 | 000 |
| 03610230004760 | K053308 | 000 |