Acro Biotech LLC Rapid Benzodiazepine Urine Test, Catalog BZD001000
FDA 510(k) K060354 · Acro Biotech, LLC
510(k) numberK060354
Submission
- Device name
- Acro Biotech LLC Rapid Benzodiazepine Urine Test, Catalog BZD001000
- Applicant
- Acro Biotech, LLC
Rancho Cucamonga, CA, US - Received
- February 13, 2006
- Decision date
- July 28, 2006
- 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
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 |
|---|---|---|
| K180771 | Acro HCG Pregnancy Rapid TestLCX · Traditional | 05/18/2018SE |
| K172512 | ACRO HCG Pregnancy Rapid TestLCX · Special | 02/02/2018SE |
| K060355 | Acro Biotech LLC Rapid Mdma Urine Test, Catalog MDMA0010000DJC · Traditional | 08/07/2006SE |
| K053037 | Acro Biotech LLC Rapid Opiates Urine Test; Catalog# OPI00100DJG · Traditional | 06/15/2006SE |
| K053034 | Acro Biotech LLC Rapid Tetrahydrocannabinol Urine Test; Catalog# OPI001000LDJ · Traditional | 06/06/2006SE |
| K053033 | Acro Biotech LLC Rapid Methamphetamine Urine Test; Catalog# MET001000DJC · Traditional | 06/06/2006SE |
| K053035 | Acro Biotech LLC Rapid Benzoylecgonine Urine Test; Catalog# MET001000DIO · Traditional | 05/05/2006SE |
| K060353 | Acro Rapid Phencyclidine Urine Test, Catalog PCP001000LCM · Traditional | 05/03/2006SE |
| K053032 | Acro Biotech LLC Rapid Amphetamine Urine Test; Catalog# AMP001000DKZ · Traditional | 02/09/2006SE |
Questions and answers
When was Acro Biotech LLC Rapid Benzodiazepine Urine Test, Catalog BZD001000 cleared by the FDA?
Acro Biotech LLC Rapid Benzodiazepine Urine Test, Catalog BZD001000 (K060354) received a 510(k) decision of Substantially Equivalent on July 28, 2006, 165 days after the submission was received.
What is the product code of K060354?
The FDA product code is JXM – Enzyme Immunoassay, Benzodiazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3170.