510(k) K100108
- Device
- AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA
- Applicant
- AMEDICA BIOTECH, INC.
- 510(k) number
- K100108
- Product code
- NGL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-04-14
- Date received
- 2010-01-14
- Regulation
- 862.3650
- Classification name
- Test, Opiates, Over The Counter
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jeff Chen
- Address
- 28301 Industrial Blvd. Suite K Hayward CA US 94545 94545
FDA Registration Numbers#
- 3043127647
- 3015821396
- 3010934853
- 3014223276
- 3007606081
- 3008741972
- 3009238284
- 3031697086
- 3023296261
- 3008054239
- 3027519599
- 3012725363
- 3016447251
- 3030413233
- 1649661
- 2060833
- 3025349997
- 2027969
- 3013223546
- 3030648160
- 3023322455
- 3010852191
- 3005345870
- 2029372
- 3031823359
- 3009585529
- 3032147516
- 3036649420
- 3013077867
- 3021186226
- 3008517993
- 3012073813
- 3005360469
- 3016609999
- 2087033
- 3010220539
- 3009414546
- 3024463179
- 3004635103
- 3005984081
- 3024753119
- 3038614708
- 1063851
- 1910144
- 2915274
- 3006048451
- 3025041446
- 3003917514
- 3009212837
- 3017904598
- 3030897502
- 3005641941
- 2030633
- 3043196750
- 3011522054
- 3014301129
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NGL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Healgen Scientific,, LLC | 2025-12-23 |
| K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | Anhui Deepblue Medical Technological Co., Ltd. | 2025-04-15 |
| K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-02-20 |
| K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-02-06 |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | Healgen Scientific,, LLC | 2024-12-17 |
| K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test | Eterbio, Inc. | 2024-11-20 |
| K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | Hangzhou Clongene Biotech Co., Ltd. | 2024-11-08 |
| K241869 | BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-10-04 |
| K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel | Qingdao Hightop Biotech Co., Ltd. | 2024-08-14 |
| K241741 | SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel | Guangzhou Wondfo Biotech Co., Ltd. | 2024-07-16 |
| K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2024-05-22 |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) | Healgen Scientific,, LLC | 2024-05-13 |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Healgen Scientific,, LLC | 2024-04-12 |
| K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | Safecare Biotech (Hangzhou) Co., Ltd. | 2024-04-10 |
| K240295 | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) | Instanosis, Inc. | 2024-03-28 |
Legacy Summary#
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FDA Review#
Decision Summary