CIBA CORNING 348 SYSTEM

Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

CIBA CORNING DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning 348 System.

Pre-market Notification Details

• Device ID: K962021
• 510k Number: K962021
• Device Name: CIBA CORNING 348 SYSTEM
• Classification: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
• Applicant: CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 -1688
• Contact: William J Pignate
• Correspondent: William J Pignate; CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 -1688
• Product Code: CHL
• Subsequent Product Code: CEM
• Subsequent Product Code: CGZ
• Subsequent Product Code: GKF
• Subsequent Product Code: JFP
• Subsequent Product Code: JGS
• CFR Regulation Number: 862.1120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-05-23
• Decision Date: 1996-06-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414115030	K962021	000
00630414056296	K962021	000
00630414055930	K962021	000
00630414055909	K962021	000
00630414053455	K962021	000
00630414053448	K962021	000