The following data is part of a premarket notification filed by Centers For Disease Control And Prevention (cdc) with the FDA for Anthracis Real-time Pcr Assay.
| Device ID | K140426 |
| 510k Number | K140426 |
| Device Name: | ANTHRACIS REAL-TIME PCR ASSAY |
| Classification | Assay, Nucleic Acid Amplification, Bacillus Anthracis |
| Applicant | CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) 1600 CLIFTON RD. NE, MS-C18 Atlanta, GA 30333 |
| Contact | Hye-joo Kim |
| Correspondent | Hye-joo Kim CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) 1600 CLIFTON RD. NE, MS-C18 Atlanta, GA 30333 |
| Product Code | NHT |
| CFR Regulation Number | 866.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-19 |
| Decision Date | 2014-05-22 |
| Summary: | summary |