510(k) K113747
- Device
- RANDOX OPIATES ASSAY
- Applicant
- RANDOX LABORATORIES LIMITED
- 510(k) number
- K113747
- Product code
- DJG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-08-24
- Date received
- 2011-12-20
- Regulation
- 862.3650
- Classification name
- Enzyme Immunoassay, Opiates
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAULINE ARMSTRONG
- Address
- 55 Diamond Rd. Crumlin GB BT29 4QY BT29 4QY
FDA Registration Numbers#
- 1063851
- 3003795116
- 3036649420
- 3043127647
- 3005641941
- 3004987297
- 3009585529
- 3023296261
- 1050155
- 2090110
- 2432235
- 9610529
- 3030413233
- 1832216
- 3009473156
- 3010220539
- 3008852306
- 3010852191
- 3030648160
- 3008416529
- 3008517993
- 3012073813
- 3005984081
- 3007838093
- 2029372
- 2027969
- 2000007960
- 1319681
- 3000308930
- 3023322455
- 2020952
- 3006048451
- 8043323
- 2087033
- 3009414546
- 3007606081
- 3005333358
- 2060833
- 3005345870
- 3010939897
- 3025041446
- 3004493545
- 3011559327
- 3024753119
- 3044466317
- 3010825766
- 3003917514
- 2031229
- 3016610313
- 2030633
- 3009212837
- 3010800486
- 3012725363
- 3013982035
- 3013684380
- 3011522054
- 2050012
- 2032364
- 3007126977
- 3010934853
- 3017904598
- 2250051
- 1649661
- 3032147516
- 2517506
- 3043196750
- 3008054239
- 3002642396
- 3008987086
- 3004175381
- 3009238284
- 2050010
- 3031697086
- 3003610499
- 3027519599
- 1910144
- 3006198300
- 2246703
- 3005360469
- 2030861
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DJG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | 2026-01-29 |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2026-01-23 |
| K253082 | LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2026-01-16 |
| K252520 | SEFRIA™ Hydrocodone Oral Fluid | Immunalysis Corporation | 2025-09-11 |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | Healgen Scientific,, LLC | 2025-08-15 |
| K251634 | LZI Fentanyl III Enzyme Immunoassay | Lin-Zhi International, Inc. | 2025-06-18 |
| K240124 | BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-06-14 |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-05-10 |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2024-03-08 |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card | Shanghai Accurature Diagnostics Co., Ltd. | 2024-02-23 |
| K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) | Hangzhou Laihe Biotech Co., Ltd. | 2024-01-09 |
| K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test | Chemtron Biotech, Inc. | 2023-12-20 |
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | Guangzhou Decheng Biotechnology Co., Ltd. | 2023-12-13 |
| K231752 | ARK Hydrocodone Assay | Ark Diagnostics, Inc. | 2023-11-09 |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2023-10-05 |
Legacy Summary#
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FDA Review#
Decision Summary