Cleared Traditional

POWER SUPPLY

K924021 · The Binding Site, Ltd. · Hematology
Jan 1993
Decision
170d
Days
Class 1
Risk

About This 510(k) Submission

K924021 is an FDA 510(k) clearance for the POWER SUPPLY, a Apparatus, Electrophoresis, For Clinical Use (Class I — General Controls, product code JJN), submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on January 28, 1993, 170 days after receiving the submission on August 11, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 862.2485.

Submission Details

510(k) Number K924021 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1992
Decision Date January 28, 1993
Days to Decision 170 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JJN — Apparatus, Electrophoresis, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2485