TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414

Drug Mixture Control Materials

BIOSITE INCORPORATED

The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Tox Drug Screen Control Level 1 Model 94413 And Level 2 Model 94414.

Pre-market Notification Details

• Device ID: K060788
• 510k Number: K060788
• Device Name: TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
• Classification: Drug Mixture Control Materials
• Applicant: BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD San Diego, CA 92121
• Contact: Robin Weiner
• Correspondent: Robin Weiner; BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD San Diego, CA 92121
• Product Code: DIF
• CFR Regulation Number: 862.3280 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-03-23
• Decision Date: 2006-07-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30014613337140	K060788	000
30014613337133	K060788	000