Cleared Traditional

SEDRATROL

K940430 · Medical Specialties Intl., Inc. · Hematology
Feb 1995
Decision
371d
Days
Class 2
Risk

About This 510(k) Submission

K940430 is an FDA 510(k) clearance for the SEDRATROL, a Control, Red-cell (Class II — Special Controls, product code GJR), submitted by Medical Specialties Intl., Inc. (South Plainfield, US). The FDA issued a Cleared decision on February 6, 1995, 371 days after receiving the submission on January 31, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K940430 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 1994
Decision Date February 06, 1995
Days to Decision 371 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJR — Control, Red-cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625