Cleared Traditional

REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)

K931503 · Helena Laboratories · Hematology
Aug 1993
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K931503 is an FDA 510(k) clearance for the REP HEMOGLOBIN IEF KITS (CAT. NO. 3250), 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 August 16, 1993, 144 days after receiving the submission on March 25, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7440.

Submission Details

510(k) Number K931503 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1993
Decision Date August 16, 1993
Days to Decision 144 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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