VARICELLA-ZOSTER(IGG) IFA TEST— 510(k) K841434
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K841434 for VARICELLA-ZOSTER(IGG) IFA TEST, Substantially Equivalent on 1985-04-19. Applicant: Zeus Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific, 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
- Raritan, NJ, 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 Zeus Scientific, Inc.
view all- K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine
- K190907 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
- K191240 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System
- K191398 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
- K113397 — ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.