Cleared Traditional

PONCEAU S STAIN SET

K792550 · Electrophoresis Corp. of America · Hematology
Jan 1980
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K792550 is an FDA 510(k) clearance for the PONCEAU S STAIN SET, a Stains, Hematology (Class I — General Controls, product code KQC), submitted by Electrophoresis Corp. of America (Mchenry, US). The FDA issued a Cleared decision on January 16, 1980, 37 days after receiving the submission on December 10, 1979. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K792550 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1979
Decision Date January 16, 1980
Days to Decision 37 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KQC — Stains, Hematology
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850