Cleared Traditional

MICROHEMATOCRIT ROTOR

K930415 · Fisher Scientific Co., LLC · Hematology
Mar 1993
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K930415 is an FDA 510(k) clearance for the MICROHEMATOCRIT ROTOR, a Centrifuge, Hematocrit (Class II — Special Controls, product code GKG), submitted by Fisher Scientific Co., LLC (Pittsburgh, US). The FDA issued a Cleared decision on March 23, 1993, 56 days after receiving the submission on January 26, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.

Submission Details

510(k) Number K930415 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1993
Decision Date March 23, 1993
Days to Decision 56 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GKG — Centrifuge, Hematocrit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6400