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)
FDA 510(k) clearance K151348 · decided 2015-08-18
Clearance details
- K-number
- K151348
- Device name
- 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
- Decision
- Substantially Equivalent
- Date received
- 2015-05-20
- Decision date
- 2015-08-18
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LFG
- Device class
- 2
- Regulation number
- 862.3910
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Bellaire, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (K142609) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-12-18 |
| WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST (K112395) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-09 |
| UCP MULTIPLE DRUG SCREEN TEST CUPS (K072062) | Ucp Biosciences, Inc. | 2007-09-20 |
| UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS (K061457) | Ucp Biosciences, Inc. | 2006-08-21 |
| ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE (K021526) | ACON Laboratories, Inc. | 2002-07-17 |
| VERDICT -II TCA, VERDICT-II MTD (K011545) | Medtox Diagnostics, Inc. | 2001-06-08 |
| ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (K980249) | Princeton BioMeditech Corp. | 1998-03-13 |
| EMIT NORTRIPTYLINE ASSAY (K870823) | Syva Co. | 1987-03-20 |
| EMIT DESIPRAMINE ASSAY (K861155) | Syva Co. | 1986-05-02 |
| TD TRICYCLIC ANTIDEPRESSANTS (K853113) | Abbott Laboratories | 1985-08-12 |
| EMIT IMIPRAMINE ASSAY (K844951) | Syva Co. | 1985-06-28 |
| EMIT DESIPRAMINE ASSAY (K844953) | Syva Co. | 1985-06-28 |
Recalls involving this device
No recalls on record reference this clearance.