STREP A OIA MAX

Antisera, All Groups, Streptococcus Spp.

BIOSTAR, INC.

The following data is part of a premarket notification filed by Biostar, Inc. with the FDA for Strep A Oia Max.

Pre-market Notification Details

• Device ID: K962060
• 510k Number: K962060
• Device Name: STREP A OIA MAX
• Classification: Antisera, All Groups, Streptococcus Spp.
• Applicant: BIOSTAR, INC. 6655 LOOKOUT RD. Boulder, CO 80301
• Contact: Lyndal K Hesterberg
• Correspondent: Lyndal K Hesterberg; BIOSTAR, INC. 6655 LOOKOUT RD. Boulder, CO 80301
• Product Code: GTZ
• CFR Regulation Number: 866.3740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-05-28
• Decision Date: 1997-07-23