LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124
FDA 510(k) clearance K093815 · decided 2010-03-12
Clearance details
- K-number
- K093815
- Device name
- LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124
- Applicant
- Millipore Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-12-14
- Decision date
- 2010-03-12
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- OMG
- Device class
- 2
- Regulation number
- 866.3980
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Temecula, CA, 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 |
|---|---|---|
| D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT (K093233) | Diagnostic Hybrids, Inc. | 2009-12-04 |
| D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT (K091171) | Diagnostic Hybrids, Inc. | 2009-09-11 |
| D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT (K090073) | Diagnostic Hybrids, Inc. | 2009-03-06 |
Recalls involving this device
No recalls on record reference this clearance.