C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST

C-reactive Protein, Antigen, Antiserum, And Control

TECO DIAGNOSTICS

The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for C-reactive Protein (crp):a Latex Slide Test.

Pre-market Notification Details

• Device ID: K962019
• 510k Number: K962019
• Device Name: C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST
• Classification: C-reactive Protein, Antigen, Antiserum, And Control
• 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: DCK
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-05-23
• Decision Date: 1996-11-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10673486002430	K962019	000