Panels › Clinical Chemistry › Product code MJZ · Class 1
Kit, Direct Antigen, Positive Control
Regulation 862.1660
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MJZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Diagnostics | 1 | 0 |
| Binax, Inc. | 1 | 0 |
| Blackhawk Biosystems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 1, 2009 | K083744 | BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 Binax, Inc. | MJZ |
| Aug 13, 1997 | K972182 | ABBOTT STREP A CONTROLS Abbott Diagnostics | MJZ |
| Aug 12, 1997 | K972129 | CHLAMYDIATROL AG Blackhawk Biosystems, Inc. | MJZ |
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