Cleared Special

VARIANT II B-THALASSEMIA

K991127 · Bio-Rad · Hematology
Jun 1999
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K991127 is an FDA 510(k) clearance for the VARIANT II B-THALASSEMIA, a Hemoglobin A2 Quantitation (Class II — Special Controls, product code JPD), submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on June 10, 1999, 69 days after receiving the submission on April 2, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7400.

Submission Details

510(k) Number K991127 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 1999
Decision Date June 10, 1999
Days to Decision 69 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

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

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