Cleared Traditional

REP ALKALINE HB-15 #3196,-8 #3197,-4 3198

K931465 · Helena Laboratories · Hematology
Jul 1993
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K931465 is an FDA 510(k) clearance for the REP ALKALINE HB-15 #3196,-8 #3197,-4 3198, 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 July 6, 1993, 104 days after receiving the submission on March 24, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7440.

Submission Details

510(k) Number K931465 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1993
Decision Date July 06, 1993
Days to Decision 104 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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