DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
FDA 510(k) clearance K200506 · decided 2020-06-03
Clearance details
- K-number
- K200506
- Device name
- DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
- Applicant
- Chembio Diagnostic Systems
- Decision
- Substantially Equivalent
- Date received
- 2020-03-02
- Decision date
- 2020-06-03
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- QFO
- Device class
- 2
- Regulation number
- 866.3935
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Medford, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set (K192046) | DiaSorin, Inc. | 2019-10-28 |
| ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control (K191578) | Siemens Healthcare Diagnostics, Inc. | 2019-07-17 |
| ZIKV Detect 2.0 IgM Capture ELISA (DEN180069) | InBios International, Inc. | 2019-05-23 |
Recalls involving this device
No recalls on record reference this clearance.