510(k) K151348
- Device
- Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
- Applicant
- HEALGEN SCIENTIFIC LLC
- 510(k) number
- K151348
- Product code
- LFG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-08-18
- Date received
- 2015-05-20
- Regulation
- 862.3910
- Classification name
- Radioimmunoassay, Tricyclic Antidepressant Drugs
- 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#
- 3043127647
- 3008416529
- 3010934853
- 3031697086
- 3009238284
- 2517506
- 3023296261
- 3027519599
- 3004987297
- 3004175381
- 2025099
- 3030413233
- 1649661
- 2060833
- 2027969
- 3030648160
- 3011559327
- 3013684380
- 3013982035
- 3005345870
- 2029372
- 3009585529
- 3036649420
- 2090110
- 3021186226
- 3008517993
- 3012073813
- 3005360469
- 3016609999
- 2087033
- 3010220539
- 3007126977
- 3010800486
- 3013679502
- 3024463179
- 3005984081
- 2246703
- 1063851
- 2915274
- 3006048451
- 3003917514
- 1050155
- 2032364
- 3009212837
- 3017904598
- 3005641941
- 2030633
- 3011522054
- 3008852306
Source Documents#
Other 510(k) Records For Product Code LFG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142609 | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine | Guangzhou Wondfo Biotech Co., Ltd. | 2014-12-18 |
| K112395 | WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-09 |
| K072062 | UCP MULTIPLE DRUG SCREEN TEST CUPS | Ucp Biosciences, Inc. | 2007-09-20 |
| K061457 | UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS | Ucp Biosciences, Inc. | 2006-08-21 |
| K021526 | ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE | ACON Laboratories, Inc. | 2002-07-17 |
| K011545 | VERDICT -II TCA, VERDICT-II MTD | Medtox Diagnostics, Inc. | 2001-06-08 |
| K980249 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | Princeton BioMeditech Corp. | 1998-03-13 |
| K870823 | EMIT NORTRIPTYLINE ASSAY | Syva Co. | 1987-03-20 |
| K861155 | EMIT DESIPRAMINE ASSAY | Syva Co. | 1986-05-02 |
| K853113 | TD TRICYCLIC ANTIDEPRESSANTS | Abbott Laboratories | 1985-08-12 |
| K844950 | EMIT AMITRIPTYLINE ASSAY | Syva Co. | 1985-06-28 |
| K844951 | EMIT IMIPRAMINE ASSAY | Syva Co. | 1985-06-28 |
| K844952 | EMIT NORTRIPTYLINE ASSAY | Syva Co. | 1985-06-28 |
| K844953 | EMIT DESIPRAMINE ASSAY | Syva Co. | 1985-06-28 |
| K841532 | ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES | E.I. Dupont DE Nemours & Co., Inc. | 1984-05-02 |
Legacy Summary#
summary
FDA Review#
Decision Summary