510(k) K890979
- Device
- Target Opiates-v
- Applicant
- V-TECH, INC.
- 510(k) number
- K890979
- Product code
- DJG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-04
- Date received
- 1989-02-27
- Regulation
- 862.3650
- Classification name
- Enzyme Immunoassay, Opiates
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- K BRUNKHORST
- Address
- 270 E. Bonita Ave. Pomona CA US 91767 91767
FDA Registration Numbers#
- 3010934853
- 3031697086
- 3009238284
- 2030861
- 3006198300
- 3030413233
- 2060833
- 3030648160
- 3010825766
- 2020952
- 3009585529
- 3032147516
- 3010800486
- 3013679502
- 2246703
- 1910144
- 3006048451
- 3003917514
- 3009212837
- 2050010
- 3005641941
- 2030633
- 3011522054
- 3005174594
- 3007606081
- 3004987297
- 3004175381
- 3012725363
- 1649661
- 3000308930
- 3008987086
- 2027969
- 3013223546
- 2031229
- 3013684380
- 3013982035
- 1220972
- 3010852191
- 2029372
- 3003795116
- 3036649420
- 3021186226
- 1832216
- 3010220539
- 3024753119
- 3044466317
- 3034694973
- 3003610499
- 2432235
- 3010939897
- 3016610313
- 3027519599
- 3005333358
- 3004493545
- 3011559327
- 3002642396
- 8043323
- 3008517993
- 3012073813
- 3005360469
- 3005755244
- 3012963943
- 3009414546
- 2250051
- 3004635103
- 2050012
- 2915274
- 3009473156
- 3025041446
- 9610529
- 3014607865
- 3043127647
- 3008416529
- 2517506
- 3007838093
- 3023296261
- 3008054239
- 2025099
- 1319808
- 3004847291
Source Documents#
510(k) summary PDF not indicated by FDA
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| K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) | Hangzhou Laihe Biotech Co., Ltd. | 2024-01-09 |
| K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test | Chemtron Biotech, Inc. | 2023-12-20 |
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | Guangzhou Decheng Biotechnology Co., Ltd. | 2023-12-13 |
| K231752 | ARK Hydrocodone Assay | Ark Diagnostics, Inc. | 2023-11-09 |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2023-10-05 |