OXOID STREPTOCOCAL GROUPING KIT

Antisera, All Groups, Streptococcus Spp.

OXOID U.S.A., INC.

The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Oxoid Streptococal Grouping Kit.

Pre-market Notification Details

• Device ID: K854929
• 510k Number: K854929
• Device Name: OXOID STREPTOCOCAL GROUPING KIT
• Classification: Antisera, All Groups, Streptococcus Spp.
• Applicant: OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045
• Contact: Ruth Kemp
• Correspondent: Ruth Kemp; OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045
• Product Code: GTZ
• CFR Regulation Number: 866.3740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-12-10
• Decision Date: 1986-03-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05032384013036	K854929	000