VARICELLA-ZOSTER ANTIGENS & CONTROLS— 510(k) K802938
Substantially EquivalentOrion Diagnostica, Inc.
FDA 510(k) clearance K802938 for VARICELLA-ZOSTER ANTIGENS & CONTROLS, Substantially Equivalent on 1980-12-31. Applicant: Orion Diagnostica, Inc.. Device class: 2.
Clearance details
- Applicant
- Orion Diagnostica, Inc.
- Product code
- Code GQW
- Device class
- Class 2
- Regulation
- 21 CFR 866.3900
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code GQW
view all- K070206 — DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
- K990141 — LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
- K964872 — VZV ANTIGEN CONTROL SLIDES
- K942743 — VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT
- K912239 — VZVSCAN(TM) LATEX AGGUTINATION TEST
More clearances from Orion Diagnostica, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.