The following data is part of a premarket notification filed by Chembio Diagnostic Systems with the FDA for Dpp Zika Igm System, Dpp Zika Igm System Control Pack, And Dpp Micro Reader.
Device ID | K200506 |
510k Number | K200506 |
Device Name: | DPP Zika IgM System, DPP Zika IgM System Control Pack, And DPP Micro Reader |
Classification | Zika Virus Serological Reagents |
Applicant | Chembio Diagnostic Systems 3661 Horseblock Road Medford, NY 11763 |
Contact | Louise Muscat Sigismondi |
Correspondent | Louise Muscat Sigismondi Chembio Diagnostic Systems 3661 Horseblock Road Medford, NY 11763 |
Product Code | QFO |
Subsequent Product Code | JJQ |
Subsequent Product Code | QCH |
CFR Regulation Number | 866.3935 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-03-02 |
Decision Date | 2020-06-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00607158000106 | K200506 | 000 |