WAKO TOTAL BILIRUBIN V

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 Total Bilirubin V.

Pre-market Notification Details

• Device ID: K970985
• 510k Number: K970985
• Device Name: WAKO TOTAL BILIRUBIN V
• Classification: Enzymatic Method, Bilirubin
• Applicant: WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237
• Contact: Tonya Mallory
• Correspondent: Tonya Mallory; 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: 1997-03-18
• Decision Date: 1997-04-21
• Summary: summary