510(k) K082977
- Device
- BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP
- Applicant
- MK BIO, INC
- 510(k) number
- K082977
- Product code
- LDJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-08-20
- Date received
- 2008-10-06
- Regulation
- 862.3870
- Classification name
- Enzyme Immunoassay, Cannabinoids
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jane Zhang
- Address
- 10239 Flanders Ct. San Diego CA US 92121 92121
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
- 2029372
- 2027969
- 2000007960
- 1319681
- 3000308930
- 3002806944
- 3023322455
- 2020952
- 3009963993
- 3006048451
- 8043323
- 2087033
- 3009414546
- 3007606081
- 3005333358
- 2060833
- 3013077867
- 3005345870
- 3010939897
- 3004493545
- 3011559327
- 3024753119
- 3010825766
- 3003917514
- 2031229
- 3016610313
- 2030633
- 3009212837
- 3010800486
- 3012725363
- 3013982035
- 3013684380
- 3011522054
- 2050012
- 2032364
- 3007126977
- 3010934853
- 3017904598
- 2250051
- 1649661
- 3032147516
- 1036362
- 2517506
- 3008054239
- 3003791481
- 3002642396
- 3008987086
- 3004175381
- 3009238284
- 2050010
- 3010131137
- 3031697086
- 3003610499
- 3027519599
- 1910144
- 3006198300
- 2246703
Source Documents#
Other 510(k) Records For Product Code LDJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 | Co-Innovation Biotech Co., Ltd. | 2024-01-17 |
| K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) | Hangzhou Laihe Biotech Co., Ltd. | 2024-01-10 |
| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT | Healgen Scientific,, LLC | 2023-03-17 |
| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019-10-11 |
| K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test | Hangzhou Clongene Biotech Co., Ltd. | 2016-03-18 |
| K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana | Nantong Egens Biotech Co., Ltd. | 2015-11-02 |
| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set | Immunalysis Corporation | 2015-06-05 |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls | Lin-Zhi International, Inc. | 2015-05-28 |
| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | Polymed Therapeutics, Inc. | 2014-09-25 |
| K140546 | HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST | Healgen Scientific,, LLC | 2014-06-06 |
| K132096 | RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR | Biophor Diagnostics, Inc. | 2013-10-18 |
| K130213 | QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE | Lumiquick Diagnostics, Inc. | 2013-10-18 |
| K122633 | TOXCUP DRUG SCREEN CUP | Branan Medical Corp. | 2013-02-07 |
| K122759 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) | Omega Laboratories, Inc. | 2012-12-05 |
| K121557 | WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2012-07-25 |
Legacy Summary#
summary
FDA Review#
Decision Summary