MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23

Enzyme Immunoassay, Opiates

BRANAN MEDICAL CORP.

The following data is part of a premarket notification filed by Branan Medical Corp. with the FDA for Monitect Oxycodone Drug Screen Cassette Test, Model Mc 23, Fastect Oxycodone Drug Screen Dipstick Test, Model Md23.

Pre-market Notification Details

• Device ID: K030113
• 510k Number: K030113
• Device Name: MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23
• Classification: Enzyme Immunoassay, Opiates
• Applicant: BRANAN MEDICAL CORP. 10015 MUIRLANDS RD., SUITE E Irvine, CA 92618
• Contact: Raphael Wong
• Correspondent: Raphael Wong; BRANAN MEDICAL CORP. 10015 MUIRLANDS RD., SUITE E Irvine, CA 92618
• Product Code: DJG
• CFR Regulation Number: 862.3650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-01-13
• Decision Date: 2003-07-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816565020984	K030113	000
00816555021076	K030113	000
00816555020123	K030113	000