ONPG DISCS

Discs, Strips And Reagents, Microorganism Differentiation

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 Onpg Discs.

Pre-market Notification Details

• Device ID: K832307
• 510k Number: K832307
• Device Name: ONPG DISCS
• Classification: Discs, Strips And Reagents, Microorganism Differentiation
• Applicant: OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JTO
• CFR Regulation Number: 866.2660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-07-14
• Decision Date: 1983-08-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05032384034154	K832307	000