STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
FDA 510(k) clearance K122019 · decided 2012-09-13
Clearance details
- K-number
- K122019
- Device name
- STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-10
- Decision date
- 2012-09-13
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- OYZ
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Meridian Bioscience
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.
Recalls involving this device
No recalls on record reference this clearance.