Cleared Traditional

AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328

K933086 · Helena Laboratories · Hematology
Oct 1994
Decision
495d
Days
Class 2
Risk

About This 510(k) Submission

K933086 is an FDA 510(k) clearance for the AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328, a Control, Hemoglobin, Abnormal (Class II — Special Controls, product code JCM), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on October 31, 1994, 495 days after receiving the submission on June 23, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number K933086 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1993
Decision Date October 31, 1994
Days to Decision 495 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JCM — Control, Hemoglobin, Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7415

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