SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS— 510(k) K914022

Name: FDA 510(k) clearance K914022
Creator: U.S. Food and Drug Administration
Published: 1992-01-27

Substantially Equivalent

Pharmacia Diagnostics, Inc.

FDA 510(k) clearance K914022 for SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS, Substantially Equivalent on 1992-01-27. Applicant: Pharmacia Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Pharmacia Diagnostics, Inc.
Product code: Code LFY
Device class: Class 2
Regulation: 21 CFR 866.3900
Advisory panel: Microbiology
Date received: 1991-09-09
Decision date: 1992-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFY

view all

K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT2023-10-27
K150375 — LIAISON VZV IgG, LIAISON Control VZV IgG2015-03-11
K070317 — ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM2007-07-05
K061820 — DIASORIN LIAISON VZV IGG2007-02-26
K051484 — ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.2005-12-05

More clearances from Pharmacia Diagnostics, Inc.

view all

K921011 — PHARMACIA CMV IGM ELISA1992-07-27
K920702 — TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO1992-07-08
K915348 — EBV-VCA IGM ELISA1992-02-14
K912026 — DELFIA(R) 17 -OH-PROGESTERON KIT1991-06-25
K902793 — RUBELLA IGG1990-07-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.