MJZ — Kit, Direct Antigen, Positive Control Class I
FDA Device Classification
Classification Details
- Product Code
- MJZ
- Device Class
- Class I
- Regulation Number
- 862.1660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K083744 | binax | BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 | September 1, 2009 |
| K972182 | abbott diagnostics | ABBOTT STREP A CONTROLS | August 13, 1997 |
| K972129 | blackhawk biosystems | CHLAMYDIATROL AG | August 12, 1997 |