EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR

Analyzer, Chemistry, Centrifugal, For Clinical Use

ABAXIS, INC.

The following data is part of a premarket notification filed by Abaxis, Inc. with the FDA for Epoc 2000 Point-of-care Analyzer And Epoc 5-chemistry Reagent Rotor.

Pre-market Notification Details

• Device ID: K934592
• 510k Number: K934592
• Device Name: EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR
• Classification: Analyzer, Chemistry, Centrifugal, For Clinical Use
• Applicant: ABAXIS, INC. 1320 CHESAPEAKE TERRACE Sunnyvale, CA 94089
• Contact: Rodger J Richeal
• Correspondent: Rodger J Richeal; ABAXIS, INC. 1320 CHESAPEAKE TERRACE Sunnyvale, CA 94089
• Product Code: JJG
• CFR Regulation Number: 862.2140 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-09-24
• Decision Date: 1994-04-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EABA40000261	K934592	000
EABA11001511	K934592	000
EABA110000001	K934592	000