Cleared Traditional

HEMOLYSE

K781121 · Electrophoresis Corp. of America · Hematology
Aug 1978
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K781121 is an FDA 510(k) clearance for the HEMOLYSE, a Products, Red-cell Lysing Products (Class I — General Controls, product code GGK), submitted by Electrophoresis Corp. of America (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978, 42 days after receiving the submission on July 3, 1978. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8540.

Submission Details

510(k) Number K781121 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1978
Decision Date August 14, 1978
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GGK — Products, Red-cell Lysing Products
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8540

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