INFLUENZA HA ANTIGEN A/USSR— 510(k) K780275

Name: FDA 510(k) clearance K780275
Creator: U.S. Food and Drug Administration
Published: 1978-02-28

Substantially Equivalent

Flow Laboratories, Inc.

FDA 510(k) clearance K780275 for INFLUENZA HA ANTIGEN A/USSR, Substantially Equivalent on 1978-02-28. Applicant: Flow Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Flow Laboratories, Inc.
Product code: Code GNT
Device class: Class 1
Regulation: 21 CFR 866.3330
Advisory panel: Microbiology
Date received: 1978-02-17
Decision date: 1978-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GNT

view all

K950838 — VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES1996-06-17
K913828 — QTEST INFLUENZA A1991-09-23
K902609 — DIRECTIGEN FLU A1990-09-10
K780272 — INFLUENZA HA ANTIGEN1978-02-28

More clearances from Flow Laboratories, Inc.

view all

K861897 — UNISKAN II1986-07-01
K862066 — TITERTEK MICROPLATE WASHER S-121986-06-05
K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE1986-05-20
K861823 — GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)1986-05-20
K861824 — GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)1986-05-20

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