510(k) K221765
- Device
- ONLINE DAT Benzodiazepines II
- Applicant
- Roche Diagnostics
- 510(k) number
- K221765
- Product code
- JXM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-23
- Date received
- 2022-06-17
- Regulation
- 862.3170
- Classification name
- Enzyme Immunoassay, Benzodiazepine
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Khoa Tran
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers
- 1063851
- 3003795116
- 3036649420
- 3043127647
- 3005641941
- 3004987297
- 3009585529
- 9680746
- 1050155
- 3023296261
- 2090110
- 2432235
- 9610529
- 3030413233
- 1832216
- 3009473156
- 3010220539
- 3008852306
- 3010852191
- 3030648160
- 3008416529
- 3008517993
- 3012073813
- 3005984081
- 3007838093
- 2029372
- 2027969
- 1319681
- 3000308930
- 3023322455
- 2020952
- 3006048451
- 2087033
- 8043323
- 3009414546
- 3007606081
- 3005333358
- 2060833
- 3005345870
- 3010939897
- 3004493545
- 3011559327
- 3010825766
- 3003917514
- 2031229
- 2030633
- 3009212837
- 3010800486
- 3012725363
- 3013982035
- 3013684380
- 3011522054
- 2050012
- 2032364
- 3007126977
- 3010934853
- 3017904598
- 2250051
- 1649661
- 2517506
- 3011989923
- 3002642396
- 3008987086
- 3004175381
- 3009238284
- 2050010
- 3031697086
- 3003610499
- 3027519599
- 1910144
- 3006198300
- 2246703
- 2132111
- 3005360469
- 2030861
- 3005174594
- 3013679502
- 2025099
- 3012963943
- 2915274
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336121054 | ONLINE DAT Benzodiazepines II | Roche Diagnostics GmbH | 2023-05-11 |
| 04015630999347 | ONLINE DAT Benzodiazepines II | Roche Diagnostics GmbH | 2023-05-11 |
Other 510(k) Records For Product Code JXM
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243498 | Alinity c Benzodiazepines Reagent Kit | Microgenics Corporation | 2024-12-11 |
| K190968 | CEDIA Benzodiazepine Assay | Microgenics Corporation | 2019-12-09 |
| K173963 | DRI Benzodiazepine Assay | Microgenics Corporation | 2018-02-21 |
| K163590 | Psychemedics Microplate EIA for Benzodiazepines in Hair | Psychemedics Corporation | 2017-09-15 |
| K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2017-08-02 |
| K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2016-05-23 |
| K151771 | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | Immunalysis Corporation | 2016-01-05 |
| K151642 | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2015-08-13 |
| K150356 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2015-05-13 |
| K123080 | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS | Chemtron Biotech, Inc. | 2012-11-29 |
| K111322 | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD | Chemtron Biotech, Inc. | 2011-09-14 |
| K092274 | RANDOX BENZODIAZEPINE ASSAY | Randox Laboratories, Ltd. | 2010-10-15 |
| K062285 | VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV | Ortho-Clinical Diagnostics, Inc. | 2006-12-22 |
| K060354 | ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000 | Acro Biotech, LLC | 2006-07-28 |
| K051307 | SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT | Beckman Coulter, Inc. | 2005-06-13 |