IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3— 510(k) K981226

Name: FDA 510(k) clearance K981226
Creator: U.S. Food and Drug Administration
Published: 1998-09-28

Substantially Equivalent

Dako Diagnostics , Ltd.

FDA 510(k) clearance K981226 for IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3, Substantially Equivalent on 1998-09-28. Applicant: Dako Diagnostics , Ltd.. Device class: 1.

Clearance details

Applicant: Dako Diagnostics , Ltd.
Product code: Code GQP
Device class: Class 1
Regulation: 21 CFR 866.3400
Advisory panel: Microbiology
Date received: 1998-03-24
Decision date: 1998-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridgeshire, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code GQP

view all

K933575 — VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT1994-11-28

More clearances from Dako Diagnostics , Ltd.

view all

K973954 — IMAGEN RESPIRATORY SCREEN1997-12-22
K962037 — IMAGEN RESPIRATORY SCREEN1996-12-26
K940564 — IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION1996-01-11
K943557 — IMAGEN1995-01-09
K932384 — IDEIA(TM) ROTAVIRUS1993-12-27

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