D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
FDA 510(k) clearance K093233 · decided 2009-12-04
Clearance details
- K-number
- K093233
- Device name
- D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
- Applicant
- Diagnostic Hybrids, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-14
- Decision date
- 2009-12-04
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- OMG
- Device class
- 2
- Regulation number
- 866.3980
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Athens, OH, 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 |
|---|---|---|
| LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 (K093815) | Millipore Corporation | 2010-03-12 |
| 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.