Cleared Traditional

HEMOGLOBIN REAGENT SET

K821202 · Omega Medical Electronics · Hematology
May 1982
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K821202 is an FDA 510(k) clearance for the HEMOGLOBIN REAGENT SET, a Cyanomethemoglobin (Class II — Special Controls, product code GKK), submitted by Omega Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on May 24, 1982, 27 days after receiving the submission on April 27, 1982. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number K821202 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1982
Decision Date May 24, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GKK — Cyanomethemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7500