Cleared Traditional

VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM

K972609 · Bio-Rad · Hematology
Aug 1997
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K972609 is an FDA 510(k) clearance for the VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM, a Fluorescent Immunoassay Gentamicin (Class II — Special Controls, product code LCQ), submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on August 6, 1997, 26 days after receiving the submission on July 11, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K972609 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1997
Decision Date August 06, 1997
Days to Decision 26 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code LCQ — Fluorescent Immunoassay Gentamicin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

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