STREP SELECTIVE II

Culture Media, Selective And Differential

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Strep Selective Ii.

Pre-market Notification Details

• Device ID: K843193
• 510k Number: K843193
• Device Name: STREP SELECTIVE II
• Classification: Culture Media, Selective And Differential
• Applicant: REMEL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JSI
• CFR Regulation Number: 866.2360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-08-14
• Decision Date: 1984-09-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00848838003158	K843193	000