Quickscreen Benzodiazepines Screening Test Model Numbers 9025,9026 and Quickscreen Pro Multi Drug Screening Test Model 1
FDA 510(k) K981687 · Phamatech
510(k) numberK981687
Submission
- Device name
- Quickscreen Benzodiazepines Screening Test Model Numbers 9025,9026 and Quickscreen Pro Multi Drug Screening Test Model 1
- Applicant
- Phamatech
San Diego, CA, US - Received
- May 13, 1998
- Decision date
- June 3, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JXM – Enzyme Immunoassay, Benzodiazepine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3170
- Specialty
- Clinical Toxicology
Other 510(k)s with product code JXM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243498 | Alinity c Benzodiazepines Reagent KitJXM · Special | Microgenics Corporation | 12/11/2024SE |
| K221765 | ONLINE DAT Benzodiazepines IIJXM · Traditional | Roche Diagnostics | 12/23/2022SE |
| K190968 | CEDIA Benzodiazepine AssayJXM · Traditional | Microgenics Corporation | 12/09/2019SE |
| K173963 | DRI Benzodiazepine AssayJXM · Traditional | Microgenics Corporation | 02/21/2018SE |
| K163590 | Psychemedics Microplate EIA for Benzodiazepines in HairJXM · Traditional | Psychemedics Corporation | 09/15/2017SE |
| K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 08/02/2017SE |
| K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 05/23/2016SE |
| K151771 | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsJXM · Traditional | Immunalysis Corporation | 01/05/2016SE |
| K151642 | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 08/13/2015SE |
| K150356 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 05/13/2015SE |
More from Healgen Scientific,, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395ZDKZ · Traditional | 10/18/2018SE |
| K131069 | Quickscreen Amphetine 500 TestDKZ · Traditional | 05/14/2014SE |
| K103295 | Quickscreen Cocaine 150 Screening TestDIO · Traditional | 02/01/2012SE |
| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening…DIS · Traditional | 12/07/2007SE |
| K070009 | At Home Drug Test Models, 9308T and 9308XDIS · Traditional | 12/07/2007SE |
| K043599 | Moments Menopause Check, Model 9113CGJ · Special | 02/25/2005SE |
| K043051 | Quickscreen Oxycodone Test, Models 9120, 9120T, 9120X and 9121DJG · Traditional | 02/07/2005SE |
| K043167 | Phamatech Quickscreen Benzodiazepines Test, Models 9025, 9026, 9027T, 9153T and 9195XJXM · Special | 12/29/2004SE |
| K041578 | Quickscreen, Models 9177X and 9178XLCM · Special | 09/10/2004SE |
| K040575 | Pharmatech Menopause Check, Models 9111 and 9112CGJ · Traditional | 05/20/2004SE |
Questions and answers
When was Quickscreen Benzodiazepines Screening Test Model Numbers 9025,9026 and Quickscreen Pro Multi Drug Screening Test Model 1 cleared by the FDA?
Quickscreen Benzodiazepines Screening Test Model Numbers 9025,9026 and Quickscreen Pro Multi Drug Screening Test Model 1 (K981687) received a 510(k) decision of Substantially Equivalent on June 3, 1998, 21 days after the submission was received.
What is the product code of K981687?
The FDA product code is JXM – Enzyme Immunoassay, Benzodiazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3170.