ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)

Counter, Differential Cell

HORIBA ABX SAS

The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Abx Micros Es 60 Ct; (open Tube Model), (close Tube Model).

Pre-market Notification Details

• Device ID: K141161
• 510k Number: K141161
• Device Name: ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)
• Classification: Counter, Differential Cell
• Applicant: HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE - BP7290 Montpellier, FR 34184
• Contact: Ferrer Caroline
• Correspondent: Ferrer Caroline; HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE - BP7290 Montpellier, FR 34184
• Product Code: GKZ
• CFR Regulation Number: 864.5220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-05-05
• Decision Date: 2014-12-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03610230006115	K141161	000
03610230006108	K141161	000
03610230006061	K141161	000
03610230006047	K141161	000