Cleared Traditional

ACID HEMOGLOBIN KIT

K992199 · Helena Laboratories · Hematology
Sep 1999
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K992199 is an FDA 510(k) clearance for the ACID HEMOGLOBIN KIT, a System, Analysis, Electrophoretic Hemoglobin (Class II — Special Controls, product code JBD), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on September 21, 1999, 83 days after receiving the submission on June 30, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7440.

Submission Details

510(k) Number K992199 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 1999
Decision Date September 21, 1999
Days to Decision 83 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JBD — System, Analysis, Electrophoretic Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7440

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