ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
FDA 510(k) clearance K093974 · decided 2010-04-22
Clearance details
- K-number
- K093974
- Device name
- ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
- Applicant
- Osmetech Molecular Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2009-12-23
- Decision date
- 2010-04-22
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- NPQ
- Device class
- 2
- Regulation number
- 864.7280
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Pasadena, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Osmetech Molecular Diagnostics
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INVADER FACTOR V (K100980) | Hologic, Inc. | 2011-06-01 |
| ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II (K093129) | Illumina, Inc. | 2010-04-28 |
| XPERT HEMOSIL FACTOR II & FACTOR V ASSAY (K082118) | Cepheid | 2009-09-18 |
| INFINITI SYSTEM (K060564) | AutoGenomics, Inc. | 2007-02-07 |
| FACTOR V LEIDEN KIT (DEN030005) | Roche Diagnostics Corp. | 2003-12-17 |
Recalls involving this device
No recalls on record reference this clearance.