The following data is part of a premarket notification filed by Centers For Disease Control And Prevention with the FDA for B. Anthracis Real-time Pcr Assay.
Device ID | K192871 |
510k Number | K192871 |
Device Name: | B. Anthracis Real-time PCR Assay |
Classification | Assay, Nucleic Acid Amplification, Bacillus Anthracis |
Applicant | Centers For Disease Control And Prevention 1600 Clifton Road NE, MS: H24-11 Atlanta, GA 30329 |
Contact | Yon Yu |
Correspondent | Julie Villanueva Centers For Disease Control And Prevention 1600 Clifton Road NE, MS: H24-11 Atlanta, GA 30329 |
Product Code | NHT |
CFR Regulation Number | 866.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-10-08 |
Decision Date | 2019-11-07 |
Summary: | summary |