RAICHEM(TM) AMMONIA REAGENT

Enzymatic Method, Ammonia

REAGENTS APPLICATIONS, INC.

The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem(tm) Ammonia Reagent.

Pre-market Notification Details

• Device ID: K864706
• 510k Number: K864706
• Device Name: RAICHEM(TM) AMMONIA REAGENT
• Classification: Enzymatic Method, Ammonia
• Applicant: REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203
• Contact: Alfred E Peacock,jr
• Correspondent: Alfred E Peacock,jr; REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203
• Product Code: JIF
• CFR Regulation Number: 862.1065 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-12-02
• Decision Date: 1987-01-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811727010278	K864706	000
00811727010261	K864706	000
00811727010254	K864706	000
00811727010247	K864706	000
00817238011438	K864706	000