IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET

Method, Enzymatic, Glucose (urinary, Non-quantitative)

TECO DIAGNOSTICS

The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for In Vitro Diagnostic Urine Reagent Strips Set.

Pre-market Notification Details

• Device ID: K942648
• 510k Number: K942648
• Device Name: IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
• Classification: Method, Enzymatic, Glucose (urinary, Non-quantitative)
• Applicant: TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670
• Contact: K. C. Chen
• Correspondent: K. C. Chen; TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670
• Product Code: JIL
• CFR Regulation Number: 862.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-06-03
• Decision Date: 1995-03-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00664816000069	K942648	000
10673486000542	K942648	000
10673486000153	K942648	000
10673486002416	K942648	000