URISCREEN

Kit, Screening, Urine

DIATECH DIAGNOSTICS,INC.

The following data is part of a premarket notification filed by Diatech Diagnostics,inc. with the FDA for Uriscreen.

Pre-market Notification Details

• Device ID: K981084
• 510k Number: K981084
• Device Name: URISCREEN
• Classification: Kit, Screening, Urine
• Applicant: DIATECH DIAGNOSTICS,INC. 15 OAK ST. Beverly Farms, MA 01915
• Contact: Fran White
• Correspondent: Fran White; DIATECH DIAGNOSTICS,INC. 15 OAK ST. Beverly Farms, MA 01915
• Product Code: JXA
• CFR Regulation Number: 866.2660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-03-25
• Decision Date: 1998-10-07
• Summary: summary