WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791

Enzymatic Method, Bilirubin

WAKO CHEMICALS, USA, INC.

The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791.

Pre-market Notification Details

• Device ID: K053132
• 510k Number: K053132
• Device Name: WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
• Classification: Enzymatic Method, Bilirubin
• Applicant: WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237
• Contact: Lori Creasy
• Correspondent: Lori Creasy; WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237
• Product Code: JFM
• CFR Regulation Number: 862.1110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-11-08
• Decision Date: 2005-12-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414595801	K053132	000
00630414513089	K053132	000
00630414513065	K053132	000