Cleared Traditional

SPIFE ALKALINE HEMOGLOBIN

K982426 · Helena Laboratories · Hematology
Dec 1998
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K982426 is an FDA 510(k) clearance for the SPIFE ALKALINE HEMOGLOBIN, a System, Analysis, Electrophoretic Hemoglobin (Class II — Special Controls, product code JBD), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on December 17, 1998, 157 days after receiving the submission on July 13, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7440.

Submission Details

510(k) Number K982426 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1998
Decision Date December 17, 1998
Days to Decision 157 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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