510(k) K091171
- Device
- D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
- Applicant
- DIAGNOSTIC HYBRIDS, INC.
- 510(k) number
- K091171
- Product code
- OMG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-09-11
- Date received
- 2009-04-22
- Regulation
- 866.3980
- Classification name
- Antisera, Fluorescent, Human Metapneumovirus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ronald H Lollar
- Address
- 1055 E. State St., Suite 100 Athens OH US 45701 45701
FDA Registration Numbers#
- 1528450
- 2030538
Source Documents#
Other 510(k) Records For Product Code OMG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093815 | LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 | Millipore Corporation | 2010-03-12 |
| K093233 | D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | 2009-12-04 |
| K090073 | D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | 2009-03-06 |
Legacy Summary#
summary
FDA Review#
Decision Summary