BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
FDA 510(k) clearance K083744 · decided 2009-09-01
Clearance details
- K-number
- K083744
- Device name
- BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
- Applicant
- Binax, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-16
- Decision date
- 2009-09-01
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- MJZ
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Scarborough, ME, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Binax
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ABBOTT STREP A CONTROLS (K972182) | Abbott Diagnostics | 1997-08-13 |
| CHLAMYDIATROL AG (K972129) | Blackhawk Biosystems, Inc. | 1997-08-12 |
Recalls involving this device
No recalls on record reference this clearance.