CARESIDE ANALYZER

Analyzer, Chemistry, Micro, For Clinical Use

EXIGENT DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Exigent Diagnostics, Inc. with the FDA for Careside Analyzer.

Pre-market Notification Details

• Device ID: K980056
• 510k Number: K980056
• Device Name: CARESIDE ANALYZER
• Classification: Analyzer, Chemistry, Micro, For Clinical Use
• Applicant: EXIGENT DIAGNOSTICS, INC. 6100 BRISTOL PKWY. Culver City, CA 90230
• Contact: Kenneth B Asarch
• Correspondent: Kenneth B Asarch; EXIGENT DIAGNOSTICS, INC. 6100 BRISTOL PKWY. Culver City, CA 90230
• Product Code: JJF
• Subsequent Product Code: CDQ
• Subsequent Product Code: CEK
• Subsequent Product Code: CIX
• CFR Regulation Number: 862.2170 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-01-06
• Decision Date: 1998-03-06
• Summary: summary