The following data is part of a premarket notification filed by Centers For Disease Control And Prevention (cdc) with the FDA for Rickettsia Real-time Pcr Assay.
| Device ID | K170940 |
| 510k Number | K170940 |
| Device Name: | Rickettsia Real-time PCR Assay |
| Classification | Rickettsia Spp. Nucleic Acid Based Detection Assay |
| Applicant | Centers For Disease Control And Prevention (CDC) 1600 Clifton Road MS-C18 Atlanta, GA 30329 |
| Contact | Yon Yu |
| Correspondent | Yon Yu Centers For Disease Control And Prevention (CDC) 1600 Clifton Road MS-C18 Atlanta, GA 30329 |
| Product Code | PVQ |
| CFR Regulation Number | 866.3316 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-30 |
| Decision Date | 2017-06-29 |