510(k) K170940
- Device
- Rickettsia Real-time PCR Assay
- Applicant
- Centers For Disease Control And Prevention (CDC)
- 510(k) number
- K170940
- Product code
- PVQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-06-29
- Date received
- 2017-03-30
- Regulation
- 866.3316
- Classification name
- Rickettsia Spp. Nucleic Acid Based Detection Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Yon Yu
- Address
- 1600 Clifton Rd. Ms-C18 Atlanta GA US 30329 30329
FDA Registration Numbers#
- 1050190
Source Documents#
Legacy Summary#
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FDA Review#
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