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 |