510(k) K170293
- Device
- Emit II Plus Cocaine Metabolite Assay
- Applicant
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- 510(k) number
- K170293
- Product code
- DIO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-10-25
- Date received
- 2017-01-31
- Regulation
- 862.3250
- Classification name
- Enzyme Immunoassay, Cocaine And Cocaine Metabolites
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALAN HALEY
- Address
- P.O. Box 6101 M/S 514 Newark DE US 19714 19714
FDA Registration Numbers#
- 1063851
- 3003795116
- 3036649420
- 3043127647
- 3005641941
- 3004987297
- 3009585529
- 3023296261
- 1050155
- 2090110
- 2432235
- 9610529
- 3030413233
- 1832216
- 3010220539
- 3008852306
- 3010852191
- 3030648160
- 3008416529
- 3008517993
- 3012073813
- 3005984081
- 3007838093
- 2029372
- 2027969
- 2000007960
- 1319681
- 3000308930
- 3002806944
- 3023322455
- 2020952
- 3009963993
- 3006048451
- 8043323
- 2087033
- 3009414546
- 3007606081
- 3005333358
- 2060833
- 3013077867
- 3005345870
- 3010939897
- 3004493545
- 3011559327
- 3010825766
- 3003917514
- 2031229
- 3016610313
- 2030633
- 3009212837
- 3010800486
- 3012725363
- 3013684380
- 3011522054
- 2050012
- 2032364
- 3007126977
- 3010934853
- 3017904598
- 2250051
- 1649661
- 1036362
- 2517506
- 3008054239
- 3002642396
- 3008987086
- 3004175381
- 3009238284
- 2050010
- 3010131137
- 3031697086
- 3003610499
- 3027519599
- 1910144
- 3006198300
- 2246703
- 3005360469
- 2030861
- 3031823359
- 3005174594
Source Documents#
Other 510(k) Records For Product Code DIO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System | Carolina Liquid Chemistries Corp. | 2022-01-27 |
| K211973 | DRI Cocaine Metabolite Assay | Microgenics Corporation | 2021-09-24 |
| K191638 | Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | Medtest DX | 2020-03-12 |
| K181499 | DRI Cocaine Metabolite Assay | Microgenics Corporation | 2018-07-06 |
| K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) | Carolina Liquid Chemistries Corporation | 2017-08-15 |
| K162395 | MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup | Mp Biomedicals, LLC | 2017-06-02 |
| K152232 | Quest Diagnostics HairCheck-DT (Cocaine) | Quest Diagnostics Incorporated | 2016-11-18 |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) | Guangzhou Wondfo Biotech Co., Ltd. | 2016-06-27 |
| K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana | Safecare Biotech (Hangzhou) Co., Ltd. | 2016-03-18 |
| K142129 | RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET | Biophor Diagnostics, Inc. | 2015-07-24 |
| K150925 | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set | Immunalysis Corporation | 2015-06-29 |
| K142353 | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test | W.H.P.M., Inc. | 2014-10-07 |
| K141647 | HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) | Healgen Scientific,, LLC | 2014-07-17 |
| K131128 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES | Omega Laboratories, Inc. | 2013-11-13 |
| K131754 | WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-07-31 |
Legacy Summary#
summary
FDA Review#
Decision Summary