Rapidone- Benzodiazepine Test
FDA 510(k) K992720 · American Bio Medica Corp.
510(k) numberK992720
Submission
- Device name
- Rapidone- Benzodiazepine Test
- Applicant
- American Bio Medica Corp.
Washington, DC, US - Received
- August 13, 1999
- Decision date
- April 3, 2000
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K170222 | Rapid Tox Cup IILAF · Traditional | 08/15/2017SE |
| K073078 | Rapid Tox CupLAG · Traditional | 05/30/2008SE |
| K060760 | Rapidone-Buprenorphine TestDJG · Traditional | 08/07/2006SE |
| K053422 | RAPIDONE-COCAINE-150 TestDIO · Traditional | 06/15/2006SE |
| K053359 | RapidtoxDKZ · Special | 05/25/2006SE |
| K041696 | Rapid ReaderDKZ · Traditional | 07/12/2005SE |
| K041712 | 'Rapidtec 4' TestDIS · Traditional | 11/03/2004SE |
| K030835 | 'Rapid One' - Propoxyphene TestJXN · Traditional | 05/22/2003SE |
| K023869 | 'RAPIDTEC'-5M-MULTIPLE Dip TestDJR · Traditional | 04/30/2003SE |
| K021114 | 'Rapidtec' 5A Multiple Dip TestDKZ · Traditional | 07/23/2002SE |
Questions and answers
When was Rapidone- Benzodiazepine Test cleared by the FDA?
Rapidone- Benzodiazepine Test (K992720) received a 510(k) decision of Substantially Equivalent on April 3, 2000, 234 days after the submission was received.
What is the product code of K992720?
The FDA product code is JXM – Enzyme Immunoassay, Benzodiazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3170.