NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4

Multi-analyte Controls, All Kinds (assayed)

NOVA BIOMEDICAL CORP.

The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Chemistry Linearity Set F, Levels 1, 2, 3, And 4.

Pre-market Notification Details

• Device ID: K955252
• 510k Number: K955252
• Device Name: NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4
• Classification: Multi-analyte Controls, All Kinds (assayed)
• Applicant: NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141
• Contact: Paul W Mac Donald
• Correspondent: Paul W Mac Donald; NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141
• Product Code: JJY
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-11-15
• Decision Date: 1996-02-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00385480412742	K955252	000