Cleared Traditional

CARESIDE HEMOGLOBIN

K001462 · Careside, Inc. · Hematology
Aug 2000
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K001462 is an FDA 510(k) clearance for the CARESIDE HEMOGLOBIN, a Whole Blood Hemoglobin Determination (Class II — Special Controls, product code KHG), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on August 21, 2000, 103 days after receiving the submission on May 10, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number K001462 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2000
Decision Date August 21, 2000
Days to Decision 103 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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