DIAGNOSTIC REAGENT SET-RPLA

Antisera, Fluorescent, All Types, Staphylococcus 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 Diagnostic Reagent Set-rpla.

Pre-market Notification Details

• Device ID: K855233
• 510k Number: K855233
• Device Name: DIAGNOSTIC REAGENT SET-RPLA
• Classification: Antisera, Fluorescent, All Types, Staphylococcus 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: GTN
• CFR Regulation Number: 866.3700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-12-31
• Decision Date: 1986-11-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05032384029587	K855233	000