Cocaine Metabolite Enzyme Immunoassay Kit
FDA 510(k) K871305 · General Diagnostics
510(k) numberK871305
Submission
- Device name
- Cocaine Metabolite Enzyme Immunoassay Kit
- Applicant
- General Diagnostics
Great Neck, NY, US - Received
- April 1, 1987
- Decision date
- June 5, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DIO – Enzyme Immunoassay, Cocaine And Cocaine Metabolites
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3250
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM)…DIO · Traditional | Carolina Liquid Chemistries Corp. | 01/27/2022SE |
| K211973 | DRI Cocaine Metabolite AssayDIO · Traditional | Microgenics Corporation | 09/24/2021SE |
| K191638 | Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayDIO · Traditional | Medtest DX | 03/12/2020SE |
| K181499 | DRI Cocaine Metabolite AssayDIO · Traditional | Microgenics Corporation | 07/06/2018SE |
| K170293 | Emit II Plus Cocaine Metabolite AssayDIO · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/25/2017SE |
| K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)DIO · Traditional | Carolina Liquid Chemistries Corporation | 08/15/2017SE |
| K162395 | MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupDIO · Special | Mp Biomedicals, LLC | 06/02/2017SE |
| K152232 | Quest Diagnostics HairCheck-DT (Cocaine)DIO · Traditional | Quest Diagnostics Incorporated | 11/18/2016SE |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC…DIO · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 06/27/2016SE |
| K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test…DIO · Traditional | Safecare Biotech (Hangzhou) Co., Ltd. | 03/18/2016SE |
More from Safecare Biotech (Hangzhou) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K882663 | Barbiturate Enzyme Immunoassay KitDIS · Traditional | 09/19/1988SE |
| K872882 | Cannabinoid Enzyme Immunoassay KitLDJ · Traditional | 11/03/1987SE |
| K864993 | Quali. Enzyme Immuno. of Barbiturates in UrineDIS · Traditional | 03/31/1987SE |
| K863877 | Benzodiazepine Enzyme Immunoassay KitJXM · Traditional | 03/12/1987SE |
| K842307 | General Diag. Cefonicid 30MCG AntimicJTN · Traditional | 07/20/1984SE |
| K841465 | General Diagnostics Platelet AntibodyLLG · Traditional | 07/02/1984SE |
| K833709 | Ceftizoxime 30 MCG Antimicrobial DiskJTN · Traditional | 12/30/1983SE |
| K832653 | Cefuroxime 30MCG. Suscep DiskJTN · Traditional | 10/14/1983SE |
| K831179 | Cefazolin 30MCG. Antimicrobial SuscepJTN · Traditional | 05/09/1983SE |
| K830731 | Netilmicin 30 MCG Antimicrobial DiskJTN · Traditional | 04/08/1983SE |
Questions and answers
When was Cocaine Metabolite Enzyme Immunoassay Kit cleared by the FDA?
Cocaine Metabolite Enzyme Immunoassay Kit (K871305) received a 510(k) decision of Substantially Equivalent on June 5, 1987, 65 days after the submission was received.
What is the product code of K871305?
The FDA product code is DIO – Enzyme Immunoassay, Cocaine And Cocaine Metabolites, a Class II (moderate risk) device regulated under 21 CFR 862.3250.