TRUST

Antigens, Nontreponemal, All

GUARDIAN SCIENTIFIC, CORP.

The following data is part of a premarket notification filed by Guardian Scientific, Corp. with the FDA for Trust.

Pre-market Notification Details

• Device ID: K954994
• 510k Number: K954994
• Device Name: TRUST
• Classification: Antigens, Nontreponemal, All
• Applicant: GUARDIAN SCIENTIFIC, CORP. 8990-E ROUTE 108 Columbia, MD 21045
• Contact: Kathryn B Powers
• Correspondent: Kathryn B Powers; GUARDIAN SCIENTIFIC, CORP. 8990-E ROUTE 108 Columbia, MD 21045
• Product Code: GMQ
• CFR Regulation Number: 866.3820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-10-31
• Decision Date: 1996-10-18