K122019 is an FDA 510(k) clearance for the STREPTOCOCCUS APP. SEROLOGICAL REAGENTS. This device is classified as a Group A Streptococcus Nucleic Acid Amplification Assay System (Class I - General Controls, product code OYZ).
Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 13, 2012, 65 days after receiving the submission on July 10, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740. An In Vitro Diagnostic Test For The Detection Of Streptococcuc Pyogenes (group A Beta Hemolytic Streptococcus) In Throat Swab Specimens From Symptomatic Patients..
| 510(k) Number | K122019 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2012 |
| Decision Date | September 13, 2012 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OYZ — Group A Streptococcus Nucleic Acid Amplification Assay System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |
| Definition | An In Vitro Diagnostic Test For The Detection Of Streptococcuc Pyogenes (group A Beta Hemolytic Streptococcus) In Throat Swab Specimens From Symptomatic Patients. |