Cleared Traditional

COLUMNMATE(TM) BETA-THAL CAT. NO. 4515

K913384 · Helena Laboratories · Hematology
Dec 1991
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K913384 is an FDA 510(k) clearance for the COLUMNMATE(TM) BETA-THAL CAT. NO. 4515, a Hemoglobin A2 Quantitation (Class II — Special Controls, product code JPD), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on December 17, 1991, 141 days after receiving the submission on July 29, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7400.

Submission Details

510(k) Number K913384 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1991
Decision Date December 17, 1991
Days to Decision 141 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JPD — Hemoglobin A2 Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7400

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