Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug Screen Dipcard
FDA 510(k) K122752 · Branan Medical Corp.
510(k) numberK122752
Submission
- Device name
- Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug Screen Dipcard
- Applicant
- Branan Medical Corp.
Irvine, CA, US - Received
- September 7, 2012
- Decision date
- January 30, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JXN – Enzyme Immunoassay, Propoxyphene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3700
- Specialty
- Clinical Toxicology
Other 510(k)s with product code JXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152495 | Wondfo Propoxyphene Urine TestJXN · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 11/23/2015SE |
| K111363 | PPX Reagent, PPX Calibrators, PPX QC MaterialJXN · Traditional | Medica Corp. | 12/06/2011SE |
| K043303 | Online Dat Propoxyphene PlusJXN · Traditional | Roche Diagnostics Corp. | 03/11/2005SE |
| K040445 | Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test DeviceJXN · Traditional | ACON Laboratories, Inc. | 05/19/2004SE |
| K030835 | 'Rapid One' - Propoxyphene TestJXN · Traditional | American Bio Medica Corp. | 05/22/2003SE |
| K023795 | Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000 Test Kit)JXN · Traditional | Lin-Zhi International, Inc. | 01/21/2003SE |
| K022915 | Instant-View Propoxyphene (PPX) Urine TestJXN · Traditional | Alfa Scientific Designs, Inc. | 11/29/2002SE |
| K020787 | Verdict-Ii PropoxypheneJXN · Traditional | Medtox Diagnostics, Inc. | 05/02/2002SE |
| K013100 | PropoxypheneJXN · Traditional | Abbott Laboratories | 03/20/2002SE |
| K011163 | Modification to the Emit II Plus Propoxyphene Assay, Model OSR9G229JXN · Special | Syva Co., Dade Behring, Inc. | 05/10/2001SE |
More from Syva Co., Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K122633 | Toxcup Drug Screen CupLDJ · Traditional | 02/07/2013SE |
| K103227 | Oratect Oral Fluid Drug Screen DevicesDIO · Traditional | 04/11/2012SE |
| K082508 | Fastect II Bup Drug Screen Dipstick and Quicktox Bup Drug Screen DipcardDJG · Traditional | 11/21/2008SE |
| K040203 | Monitect Mdma Drug Screen Cassette Test, Model MC22; Fastect II Mdma Drug Screen…DKZ · Traditional | 03/25/2004SE |
| K032057 | Toxcup Drug Screen Cup Amp/Coc/Met/Opi/Pcp/ThcDIO · Special | 08/21/2003SE |
| K030113 | Monitect Oxycodone Drug Screen Cassette Test, Model MC 23, Fastect Oxycodone Drug Screen…DJG · Traditional | 07/02/2003SE |
| K023489 | Quicktox Multiple Drug DipcardDIO · Special | 12/16/2002SE |
| K022355 | Quicktox Multiple Drug Dipcard Coc/Met/Thc/Amp/Pcp/Bzo/Bar/Mtd/Tca, Model QT61DIO · Special | 07/30/2002SE |
| K013124 | Modification to Scooper Drug/Adulteration Test CupDJJ · Special | 11/07/2001SE |
| K012541 | Modification To:Fastix Thc/Coc Drug Screen Dipstick Test, Fastix Thc/Coc/Met Drug Screen…LDJ · Special | 09/04/2001SE |
Questions and answers
When was Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug Screen Dipcard cleared by the FDA?
Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug Screen Dipcard (K122752) received a 510(k) decision of Substantially Equivalent on January 30, 2013, 145 days after the submission was received.
What is the product code of K122752?
The FDA product code is JXN – Enzyme Immunoassay, Propoxyphene, a Class II (moderate risk) device regulated under 21 CFR 862.3700.