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 |