D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT— 510(k) K090073
Substantially EquivalentDiagnostic Hybrids, Inc.
FDA 510(k) clearance K090073 for D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT, Substantially Equivalent on 2009-03-06. Applicant: Diagnostic Hybrids, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Hybrids, Inc.
- Product code
- Code OMG
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Athens, OH, US
Recent devices under product code OMG
view allMore clearances from Diagnostic Hybrids, Inc.
view all- DEN140004 — QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
- K092229 — THYRETAIN TM TSI REPORTER BIOASSAY
- K093415 — D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
- K092882 — D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
- K091753 — ELVIS HSV ID AND D3 TYPING TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.