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FDA 510(k), K060540, XPERT, GENEXPERT DX SYSTEM
FDA 510(k), K060540, XPERT, GENEXPERT DX SYSTEM
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510(K) Number: K060540
Device Name: XPERT, GENEXPERT DX SYSTEM
Manufacturer: RUSSEL K ENNS
Device Classification Name: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Regulation Number: NJR
Classification Product Code: KXA
Date Received: 03/01/2006
Decision Date: 07/25/2006
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: XPERT, GENEXPERT DX SYSTEM
Manufacturer: RUSSEL K ENNS
Device Classification Name: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Regulation Number: NJR
Classification Product Code: KXA
Date Received: 03/01/2006
Decision Date: 07/25/2006
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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