ONYX

Counter, Differential Cell

COULTER CORP.

The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Onyx.

Pre-market Notification Details

• Device ID: K943967
• 510k Number: K943967
• Device Name: ONYX
• Classification: Counter, Differential Cell
• Applicant: COULTER CORP. 11800 S.W. 147TH AVE. MAIL CODE 31-B06 Miami, FL 33196 -2500
• Contact: Benita B Bourque
• Correspondent: Benita B Bourque; COULTER CORP. 11800 S.W. 147TH AVE. MAIL CODE 31-B06 Miami, FL 33196 -2500
• Product Code: GKZ
• CFR Regulation Number: 864.5220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-08-15
• Decision Date: 1995-03-06