DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000— 510(k) K070265
Substantially EquivalentDiagnostic Hybrids, Inc.
FDA 510(k) clearance K070265 for DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000, Substantially Equivalent on 2007-10-24. Applicant: Diagnostic Hybrids, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Hybrids, Inc.
- Product code
- Code GQN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Athens, OH, US
Recent devices under product code GQN
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
- K093233 — D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
- K092882 — D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.