DYNEX SmartPLEX MMRV IgG Assay Kit
FDA 510(k) clearance K212769 · decided 2023-09-29
Clearance details
- K-number
- K212769
- Device name
- DYNEX SmartPLEX MMRV IgG Assay Kit
- Applicant
- Dynex Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-08-31
- Decision date
- 2023-09-29
- Days to decision
- 759 days
- Clearance type
- Traditional
- Product code
- OPL
- Device class
- 2
- Regulation number
- 866.3510
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Chantilly, VA, 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 |
|---|---|---|
| BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL (K111072) | Bio-Rad Laboratories | 2011-08-23 |
| BIOPLEX 2200 MMRV IGG (K091616) | Bio-Rad Laboratories | 2010-03-29 |
Recalls involving this device
No recalls on record reference this clearance.