510(k) K080347
- Device
- UNISCAN -DOA SYSTEM
- Applicant
- TAIWAN UNISON BIOTECH, INC.
- 510(k) number
- K080347
- Product code
- DJC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-10-09
- Date received
- 2008-02-08
- Regulation
- 862.3610
- Classification name
- Thin Layer Chromatography, Methamphetamine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- KUANG-PIN HSIUNG
- Address
- 3f, # 22, Kedung 3rd Rd. Chunan, Miaoli TW 350 350
FDA Registration Numbers#
- 3005174594
- 3043127647
- 3008416529
- 3010934853
- 3009238284
- 3023296261
- 3008054239
- 3016610313
- 3027519599
- 3004175381
- 3004987297
- 3012725363
- 3030413233
- 2060833
- 3004493545
- 2027969
- 3030648160
- 3011559327
- 3013684380
- 3010852191
- 3005345870
- 2029372
- 3008852306
- 3031823359
- 3009585529
- 3036649420
- 2090110
- 3021186226
- 3008517993
- 3012073813
- 3005360469
- 1832216
- 3010220539
- 2087033
- 3010800486
- 3007126977
- 3013679502
- 3009414546
- 3024463179
- 3005984081
- 2246703
- 1063851
- 2915274
- 3009473156
- 3003917514
- 1050155
- 2032364
- 3017904598
- 3005641941
- 2030633
- 3043196750
- 3011522054
- 3014607865
Source Documents#
Other 510(k) Records For Product Code DJC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253705 | Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC | 2026-03-16 |
| K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | Hangzhou Laihe Biotech Co., Ltd. | 2025-03-18 |
| K180878 | BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx | Shanghai Venture Bio-Tech Co., Ltd. | 2018-12-17 |
| K181305 | OralTox Oral fluid Drug Test | Premier Biotech, Inc. | 2018-09-20 |
| K171403 | OralTox Oral Fluid Drug Test | Premier Biotech, Inc. | 2018-02-02 |
| K161044 | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | Assure Tech. (Hangzhou) Co, Ltd. | 2016-07-06 |
| K132630 | WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-09-27 |
| K060355 | ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 | Acro Biotech, LLC | 2006-08-07 |
| K060896 | MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT | Varian, Inc. | 2006-06-09 |
| K053033 | ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 | Acro Biotech, LLC | 2006-06-06 |
| K031497 | AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST | Amedica Biotech, Inc. | 2003-10-17 |
| K022388 | STARTOX DRUG OF ABUSE SCREENING TEST (4) | Starplex Scientific, Inc. | 2003-02-27 |
| K022501 | INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST | Alfa Scientific Designs, Inc. | 2002-11-13 |
| K022141 | VERDICT-II | Medtox Diagnostics, Inc. | 2002-07-30 |
| K011185 | PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY | Psychemedics Corp. | 2002-01-24 |
Legacy Summary#
summary
FDA Review#
Decision Summary