FDA Product Code
FDA Product Code MJZ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1660
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K083744 | BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 | Binax, Inc. | 2009-09-01 | Traditional | PDF ↗ |
| K972182 | ABBOTT STREP A CONTROLS | Abbott Diagnostics | 1997-08-13 | Traditional | PDF ↗ |
| K972129 | CHLAMYDIATROL AG | Blackhawk Biosystems, Inc. | 1997-08-12 | Traditional | PDF ↗ |
Product code MJZ · Class I · Clinical Chemistry. Data: openFDA.