510(k) K112125
K112125 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT". The FDA issued a decision of Substantially Equivalent on December 5, 2011. The device falls under product code NJR (Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test), a Class I device regulated under 21 CFR 866.3740. Meridian Bioscience, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2011
- Date Received
- July 25, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
- Device Class
- Class I
- Regulation Number
- 866.3740
- Review Panel
- MI
- Submission Type
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.