RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY— 510(k) K922801

Name: FDA 510(k) clearance K922801
Creator: U.S. Food and Drug Administration
Published: 1993-01-06

Substantially Equivalent

Light Diagnostics

FDA 510(k) clearance K922801 for RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY, Substantially Equivalent on 1993-01-06. Applicant: Light Diagnostics. Device class: 1.

Clearance details

Applicant: Light Diagnostics
Product code: Code GNY
Device class: Class 1
Regulation: 21 CFR 866.3020
Advisory panel: Microbiology
Date received: 1992-06-10
Decision date: 1993-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GNY

view all

K885310 — MURINE MONOCLONAL ANTI-ADENOVIRUS IGG1989-02-16
K770807 — ADENOVIRUS-GROUP FA LABELLED (8-651 RF)1977-05-20
K770811 — ADENOVIRUS GROUP-FA LABELLED PRESERUM1977-05-20

More clearances from Light Diagnostics

view all

K991880 — LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY1999-11-09
K990141 — LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 32951999-10-19
K972975 — LIGHT DIAGNOSTICS RABIES DFA REAGENT1998-12-22
K974302 — LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B1998-04-08
K951821 — CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY1996-06-07

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