Cleared Traditional

RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367

K050709 · Wallac OY · Hematology
Mar 2006
Decision
355d
Days
Class 2
Risk

About This 510(k) Submission

K050709 is an FDA 510(k) clearance for the RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367, a Abnormal Hemoglobin Quantitation (Class II — Special Controls, product code GKA), submitted by Wallac OY (Turku, FI). The FDA issued a Cleared decision on March 8, 2006, 355 days after receiving the submission on March 18, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number K050709 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2005
Decision Date March 08, 2006
Days to Decision 355 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKA — Abnormal Hemoglobin Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7415

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