RADS

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

CHASON HEALTHCARE, LLC.

The following data is part of a premarket notification filed by Chason Healthcare, Llc. with the FDA for Rads.

Pre-market Notification Details

• Device ID: K011054
• 510k Number: K011054
• Device Name: RADS
• Classification: Enzyme Immunoassay, Cocaine And Cocaine Metabolites
• Applicant: CHASON HEALTHCARE, LLC. 715 BUCKEYE TERRACE Rock Hill Sc, SC 29732
• Contact: Charles F Neilson
• Correspondent: Charles F Neilson; CHASON HEALTHCARE, LLC. 715 BUCKEYE TERRACE Rock Hill Sc, SC 29732
• Product Code: DIO
• Subsequent Product Code: DJG
• Subsequent Product Code: DKZ
• Subsequent Product Code: LCM
• Subsequent Product Code: LKJ
• CFR Regulation Number: 862.3250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-04-06
• Decision Date: 2001-07-30