510(k) K083744
- Device
- BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
- Applicant
- BINAX, INC.
- 510(k) number
- K083744
- Product code
- MJZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-09-01
- Date received
- 2008-12-16
- Regulation
- 862.1660
- Classification name
- Kit, Direct Antigen, Positive Control
- Medical specialty
- Clinical Chemistry
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Anne Jepson
- Address
- 10 Southgate Rd. Scarborough ME US 04074 04074
FDA Registration Numbers#
- 1221359
- 3007606081
- 3017662853
- 3014150341
- 3023322455
- 3004635103
- 3004146366
- 3016252795
Source Documents#
Other 510(k) Records For Product Code MJZ #
Legacy Summary#
summary
FDA Review#
Decision Summary