Cleared Traditional

ECA HEME BUFFER

K781119 · Electrophoresis Corp. of America · Chemistry
Aug 1978
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K781119 is an FDA 510(k) clearance for the ECA HEME BUFFER, a System, Analysis, Electrophoretic Hemoglobin (Class II — Special Controls, product code JBD), 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 Chemistry review panel. Regulated under 21 CFR 864.7440.

Submission Details

510(k) Number K781119 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 Chemistry (CH)
Summary —

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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