Cleared Traditional

ANEMIAPRO SELF-SCREENER

K042379 · Biosafe Laboratories, Inc. · Hematology
Dec 2004
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K042379 is an FDA 510(k) clearance for the ANEMIAPRO SELF-SCREENER, a Whole Blood Hemoglobin Determination (Class II — Special Controls, product code KHG), submitted by Biosafe Laboratories, Inc. (Lake Forest, US). The FDA issued a Cleared decision on December 15, 2004, 105 days after receiving the submission on September 1, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number K042379 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2004
Decision Date December 15, 2004
Days to Decision 105 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KHG — Whole Blood Hemoglobin Determination
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7500

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