Accusign Doa 3/DOA 3 (Bzo/Bar/Pcp), Bzo/Bar/Pcp, Biosign Doa 3/BZO/BAR/PCP, Biosign Bzo/Bar/Pcp
FDA 510(k) K961325 · Princeton BioMeditech Corp.
510(k) numberK961325
Submission
- Device name
- Accusign Doa 3/DOA 3 (Bzo/Bar/Pcp), Bzo/Bar/Pcp, Biosign Doa 3/BZO/BAR/PCP, Biosign Bzo/Bar/Pcp
- Applicant
- Princeton BioMeditech Corp.
Monmouth Junction, NJ, US - Received
- April 8, 1996
- Decision date
- June 12, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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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 |
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Questions and answers
When was Accusign Doa 3/DOA 3 (Bzo/Bar/Pcp), Bzo/Bar/Pcp, Biosign Doa 3/BZO/BAR/PCP, Biosign Bzo/Bar/Pcp cleared by the FDA?
Accusign Doa 3/DOA 3 (Bzo/Bar/Pcp), Bzo/Bar/Pcp, Biosign Doa 3/BZO/BAR/PCP, Biosign Bzo/Bar/Pcp (K961325) received a 510(k) decision of Substantially Equivalent on June 12, 1996, 65 days after the submission was received.
What is the product code of K961325?
The FDA product code is JXM – Enzyme Immunoassay, Benzodiazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3170.