Cleared Traditional

HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)

K991362 · Morax · Hematology
Jun 1999
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K991362 is an FDA 510(k) clearance for the HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO), a System, Analysis, Electrophoretic Hemoglobin (Class II — Special Controls, product code JBD), submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on June 21, 1999, 68 days after receiving the submission on April 14, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7440.

Submission Details

510(k) Number K991362 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1999
Decision Date June 21, 1999
Days to Decision 68 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JBD — System, Analysis, Electrophoretic Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7440

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