SAS ADENO TEST

Antigens, Cf (including Cf Control), Adenovirus 1-33

SA SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Adeno Test.

Pre-market Notification Details

• Device ID: K990630
• 510k Number: K990630
• Device Name: SAS ADENO TEST
• Classification: Antigens, Cf (including Cf Control), Adenovirus 1-33
• Applicant: SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240
• Contact: J. Wessling
• Correspondent: J. Wessling; SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240
• Product Code: GOD
• CFR Regulation Number: 866.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-02-26
• Decision Date: 1999-08-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00722066001905	K990630	000