510(k) K150791
- Device
- Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
- Applicant
- HEALGEN SCIENTIFIC LLC
- 510(k) number
- K150791
- Product code
- DIS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-24
- Date received
- 2015-03-25
- Regulation
- 862.3150
- Classification name
- Enzyme Immunoassay, Barbiturate
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JIANQIU FANG
- Address
- 5213 Maple St. Bellaire TX US 77401 77401
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
- 8020888
- 2029372
- 2027969
- 1319681
- 3000308930
- 3023322455
- 2020952
- 3006048451
- 8043323
- 2087033
- 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
- 3002642396
- 3008987086
- 3004175381
- 3009238284
- 2050010
- 1219913
- 3031697086
- 3003610499
- 3027519599
- 1910144
- 3006198300
- 2246703
- 3005360469
- 2030861
- 3005174594
- 3013679502
- 2025099
- 3012963943
- 2915274
- 1319808
- 3024463179
- 1827821
Source Documents#
Other 510(k) Records For Product Code DIS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | Immunalysis Corporation | 2016-10-14 |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup | Assure Tech. Co., Ltd. | 2015-06-04 |
| K143535 | CR3 Keyless Split Sample Cup Secobarbital- Methadone | Guangzhou Wondfo Biotech Co., Ltd. | 2015-01-13 |
| K140665 | GenPrime Snap-Top Split Key Cup | Genprime, Inc. | 2014-12-08 |
| K140215 | ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD | Co-Innovation Biotech Co., Ltd. | 2014-06-16 |
| K092268 | RANDOX BARITURATES ASSAY | Randox Laboratories, Ltd. | 2011-05-25 |
| K110515 | UCP DRUG SCREENING TEST CUPS | Ucp Biosciences, Inc. | 2011-04-20 |
| K070009 | AT HOME DRUG TEST MODELS, 9308T AND 9308X | Phamatech, Inc. | 2007-12-07 |
| K070098 | QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC | Phamatech, Inc. | 2007-12-07 |
| K062165 | VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS | Ortho-Clinical Diagnostics | 2007-01-05 |
| K050024 | ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS | Guangzhou Wondfo Biotech Co., Ltd. | 2005-11-17 |
| K050593 | ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE | ACON Laboratories, Inc. | 2005-05-06 |
| K043211 | ONLINE DAT BARBITURATES PLUS | Roche Diagnostics Corp. | 2004-12-29 |
| K042975 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II | Ameditech, Inc. | 2004-12-29 |
| K041143 | RANDOX BARBITURATE ASSAY | Randox Laboratories, Ltd. | 2004-11-05 |
Legacy Summary#
summary
FDA Review#
Decision Summary