FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY— 510(k) K052115
Substantially EquivalentFirst Check Diagnostics, LLC
FDA 510(k) clearance K052115 for FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY, Substantially Equivalent on 2005-12-29. Applicant: First Check Diagnostics, LLC. Device class: 2.
Clearance details
- Applicant
- First Check Diagnostics, LLC
- Product code
- Code DKZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, CA, US
Recent devices under product code DKZ
view allRecalls naming K052115
K-number listed on FDA's recall record- Z-3031-2020 — Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup¿ DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/BUPG/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC/TCA Bl, Cr, Ni, pH, SG", I-DXA-1127-023-N "Alere" iCup¿ Dx Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+ (OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G."
- Z-3036-2020 — ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug Detection: (COC300/THC50)+AMP1000+BZO300+BUP10+MET500+MTD300+OPI300 NO ADULTERATION", IMCA-8CM5 /"ImmuTest Drugs of Abuse Cup (OXY100/MDMA500)+(PCP25/AMP1000)+COC150+MET500+OPI2000+THC50 with Cr, Ni, pH, Bl, S.G."
- Z-3042-2020 — ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO
- Z-3046-2020 — First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B
- Z-3048-2020 — First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B
- Z-3049-2020 — First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
- Z-3050-2020 — First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B
- Z-0484-2016 — 1 Step 12 Panel Cup, Item No. NBCA-12M-W
- Z-0485-2016 — 10-Panel Pipette Drug Screen, Item No. PSP-10M
- Z-0486-2016 — 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA
- Z-0487-2016 — 11 Panel Card (OPI 300) w/Adult, Item No. 71125AA
- Z-0488-2016 — 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.
- Z-0489-2016 — 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP
- Z-0490-2016 — BZO Strip Dip Card (300ng/ml)*, Item No. 100170
- Z-0491-2016 — CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5
- Z-0492-2016 — DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5
- Z-0493-2016 — DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D
- Z-0494-2016 — DrugSmart 11 Test Cup, Item No. 61127D
- Z-0495-2016 — DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D
- Z-0496-2016 — DrugSmart 9 Test Cup (BUP), Item No. 60960D
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052115.
Data sourced from openFDA. This site is unofficial and independent of the FDA.