IDEIA(TM) ROTAVIRUS— 510(k) K932384

Substantially Equivalent

Dako Diagnostics , Ltd.

FDA 510(k) clearance K932384 for IDEIA(TM) ROTAVIRUS, Substantially Equivalent on 1993-12-27. Applicant: Dako Diagnostics , Ltd.. Device class: 1.

Clearance details

Applicant: Dako Diagnostics , Ltd.
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1993-05-17
Decision date: 1993-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridgeshire, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIQ

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K964424 — ROTAVIRUS EIA1997-08-08
K965092 — VIDAS ROTAVIRUS ASSAY1997-05-05

More clearances from Dako Diagnostics , Ltd.

K981226 — IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 31998-09-28
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

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