510(k) K093815
- Device
- LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124
- Applicant
- MILLIPORE CORPORATION
- 510(k) number
- K093815
- Product code
- OMG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-03-12
- Date received
- 2009-12-14
- 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
- CATHERINE KARAMAN
- Address
- 28820 Single Oak Dr. Temecula CA US 92590 92590
FDA Registration Numbers#
- 1528450
- 2030538
Source Documents#
Other 510(k) Records For Product Code OMG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093233 | D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | 2009-12-04 |
| K091171 | D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | 2009-09-11 |
| K090073 | D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | 2009-03-06 |
Legacy Summary#
summary
FDA Review#
Decision Summary