BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
FDA 510(k) clearance K181711 · decided 2018-08-15
Clearance details
- K-number
- K181711
- Device name
- BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
- Applicant
- Microbiologics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-28
- Decision date
- 2018-08-15
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- PMN
- Device class
- 2
- Regulation number
- 866.3920
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- St. Cloud, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Microbiologics
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.
Recalls involving this device
No recalls on record reference this clearance.