THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120

System, Test, Thyroid Autoantibody

THERATEST LABORATORIES, INC.

The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for Theratest El-anti-tpo And Theratest El-anti-thyroglobulin, Model 104-119, 103-120.

Pre-market Notification Details

• Device ID: K090760
• 510k Number: K090760
• Device Name: THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
• Classification: System, Test, Thyroid Autoantibody
• Applicant: THERATEST LABORATORIES, INC. 1111 N. MAIN ST. Lombard, IL 60148
• Contact: Gabriella Lakos
• Correspondent: Gabriella Lakos; THERATEST LABORATORIES, INC. 1111 N. MAIN ST. Lombard, IL 60148
• Product Code: JZO
• CFR Regulation Number: 866.5870 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-03-23
• Decision Date: 2009-09-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00854473003262	K090760	000
00854473003255	K090760	000