UCP HOME DRUG SCREENING TEST; CARDS, CUPS

Enzyme Immunoassay, Amphetamine

UCP BIOSCIENCES, INC.

The following data is part of a premarket notification filed by Ucp Biosciences, Inc. with the FDA for Ucp Home Drug Screening Test; Cards, Cups.

Pre-market Notification Details

• Device ID: K130463
• 510k Number: K130463
• Device Name: UCP HOME DRUG SCREENING TEST; CARDS, CUPS
• Classification: Enzyme Immunoassay, Amphetamine
• Applicant: UCP BIOSCIENCES, INC. 1445 KOLL CIRCLE, STE. 111 San Jose, CA 95112
• Contact: Nancy Chen
• Correspondent: Nancy Chen; UCP BIOSCIENCES, INC. 1445 KOLL CIRCLE, STE. 111 San Jose, CA 95112
• Product Code: DKZ
• Subsequent Product Code: DIO
• Subsequent Product Code: DIS
• Subsequent Product Code: DJC
• Subsequent Product Code: DJG
• Subsequent Product Code: DJR
• Subsequent Product Code: JXM
• Subsequent Product Code: JXN
• Subsequent Product Code: LCM
• Subsequent Product Code: LDJ
• Subsequent Product Code: LFG
• CFR Regulation Number: 862.3100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-02-22
• Decision Date: 2013-05-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850013035212	K130463	000
20817038021792	K130463	000
20817038021808	K130463	000
20817038021921	K130463	000
10850721007003	K130463	000
10850721007010	K130463	000
20850721007048	K130463	000
20850721007062	K130463	000
20850721007079	K130463	000
20850721007086	K130463	000
20850721007093	K130463	000
20850721007130	K130463	000
20817038021631	K130463	000
20817038021594	K130463	000
20817038020511	K130463	000
20817038020825	K130463	000
20817038020863	K130463	000
20817038021204	K130463	000
20817038021464	K130463	000
20817038020580	K130463	000
20817038020597	K130463	000
20817038020603	K130463	000
20817038020610	K130463	000
20817038020634	K130463	000
20817038020641	K130463	000
20850721007147	K130463	000
20850721007154	K130463	000
20850721007161	K130463	000
20850721007727	K130463	000
20850721007734	K130463	000
20850721007741	K130463	000
20850721007758	K130463	000
00850013035083	K130463	000
00850013035090	K130463	000
00850013035106	K130463	000
00850013035113	K130463	000
00850013035045	K130463	000
20850013035056	K130463	000
20850013035063	K130463	000
20850721007581	K130463	000
20850721007529	K130463	000
20850721007178	K130463	000
20850721007185	K130463	000
20850721007192	K130463	000
20850721007208	K130463	000
20850721007215	K130463	000
20850721007222	K130463	000
20850721007239	K130463	000
20850721007246	K130463	000
20850721007253	K130463	000
20850721007260	K130463	000
20850721007277	K130463	000
20850013035070	K130463	000