Cleared Traditional

VARIANT BETA-THALASSEMIA SHORT PROGRAM

K924122 · Bio-Rad · Hematology
Mar 1993
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K924122 is an FDA 510(k) clearance for the VARIANT BETA-THALASSEMIA SHORT PROGRAM, a Hemoglobin A2 Quantitation (Class II — Special Controls, product code JPD), submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on March 11, 1993, 209 days after receiving the submission on August 14, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7400.

Submission Details

510(k) Number K924122 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1992
Decision Date March 11, 1993
Days to Decision 209 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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