Cleared Traditional

COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL

K923318 · Helena Laboratories · Hematology
Aug 1992
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K923318 is an FDA 510(k) clearance for the COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL, a Hemoglobin A2 Quantitation (Class II — Special Controls, product code JPD), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on August 25, 1992, 49 days after receiving the submission on July 7, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7400.

Submission Details

510(k) Number K923318 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1992
Decision Date August 25, 1992
Days to Decision 49 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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