The following data is part of a premarket notification filed by Ucp Biosciences, Inc. with the FDA for Ucp Compact Drug Test Cards, Ucp Compact Drug Test Cups.
| Device ID | K131811 |
| 510k Number | K131811 |
| Device Name: | UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-19 |
| Decision Date | 2013-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817038022249 | K131811 | 000 |
| 20817038022119 | K131811 | 000 |
| 20817038022096 | K131811 | 000 |
| 20817038022072 | K131811 | 000 |
| 20817038022065 | K131811 | 000 |
| 20817038021952 | K131811 | 000 |
| 20817038021969 | K131811 | 000 |
| 20817038021976 | K131811 | 000 |
| 20817038022058 | K131811 | 000 |
| 20817038022164 | K131811 | 000 |
| 20817038022157 | K131811 | 000 |
| 20817038022140 | K131811 | 000 |
| 20817038022225 | K131811 | 000 |
| 20817038022232 | K131811 | 000 |
| 00850040879162 | K131811 | 000 |
| 20817038022218 | K131811 | 000 |
| 20817038022171 | K131811 | 000 |
| 20817038022188 | K131811 | 000 |
| 20817038022126 | K131811 | 000 |
| 20817038022133 | K131811 | 000 |
| 20850721007574 | K131811 | 000 |
| 20850721007666 | K131811 | 000 |
| 20850721007789 | K131811 | 000 |
| 20850721007796 | K131811 | 000 |
| 20850721007802 | K131811 | 000 |
| 20850721007963 | K131811 | 000 |
| 20850721007970 | K131811 | 000 |
| 20850721007987 | K131811 | 000 |
| 10850721007959 | K131811 | 000 |
| 20850721007871 | K131811 | 000 |
| 10817038022020 | K131811 | 000 |
| 10817038022013 | K131811 | 000 |
| 20817038022041 | K131811 | 000 |
| 20850721007673 | K131811 | 000 |
| 20850721007680 | K131811 | 000 |
| 20850721007697 | K131811 | 000 |
| 20850721007703 | K131811 | 000 |
| 20850721007710 | K131811 | 000 |
| 20850721007765 | K131811 | 000 |
| 20850721007772 | K131811 | 000 |
| 20850721007819 | K131811 | 000 |
| 20850721007864 | K131811 | 000 |