MycoMEIA Aspergillus Assay
FDA 510(k) clearance K243496 · decided 2025-08-01
Clearance details
- K-number
- K243496
- Device name
- MycoMEIA Aspergillus Assay
- Applicant
- Pearl Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-12
- Decision date
- 2025-08-01
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- NOM
- Device class
- 1
- Regulation number
- 866.3040
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Baltimore, MD, 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 |
|---|---|---|
| PLATELIA ASPERGILLUS EIA MODEL 62793 (K093678) | Bio-Rad | 2011-01-13 |
| PLATELIA ASPERGILLUS EIA, MODEL 62793 (K060641) | Bio-Rad | 2006-06-02 |
| PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 (K023857) | Bio-Rad | 2003-05-16 |
Recalls involving this device
No recalls on record reference this clearance.