Binaxnow Malaria Positive Control Kit, Model 665-010
FDA 510(k) K083744 · Binax, Inc.
510(k) numberK083744
Submission
- Device name
- Binaxnow Malaria Positive Control Kit, Model 665-010
- Applicant
- Binax, Inc.
Scarborough, ME, US - Received
- December 16, 2008
- Decision date
- September 1, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJZ – Kit, Direct Antigen, Positive Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MJZ
More from Blackhawk Biosystems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K090301 | Binaxnow PBP2A Test, Model 890-000MYI · Traditional | 04/14/2010SE |
| K091766 | Clearview Exact PBP2A Test, Model 891-000MYI · Traditional | 02/24/2010SE |
| K090964 | Binaxnox Staphylococcus Aureus TestJWX · Traditional | 12/16/2009SE |
| K091489 | Clearview Advanced Strep a , Model 737-430GTY · Traditional | 09/04/2009SE |
| K092223 | Modification to: Binaxnow Influenza a & B TestPSZ · Special | 08/12/2009SE |
| K080003 | Binaxnow G6PD TestJBF · Traditional | 10/23/2008SE |
| K062109 | Binaxnow Influenza a & B TestPSZ · Traditional | 11/09/2006SE |
| K053126 | Binaxnow Influenza a & B TestPSZ · Traditional | 11/30/2005SE |
| K041049 | Binaxnow Influenza a & B TestPSZ · Traditional | 08/10/2004SE |
| K032166 | Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack…GQG · Traditional | 10/21/2003SE |
Questions and answers
When was Binaxnow Malaria Positive Control Kit, Model 665-010 cleared by the FDA?
Binaxnow Malaria Positive Control Kit, Model 665-010 (K083744) received a 510(k) decision of Substantially Equivalent on September 1, 2009, 259 days after the submission was received.
What is the product code of K083744?
The FDA product code is MJZ – Kit, Direct Antigen, Positive Control, a Class I (low risk) device regulated under 21 CFR 862.1660.