Cleared Traditional

25 CM2, 75 CM2, 125 CM2 FLASK, CATALOG #03-291

K930390 · Proteins Intl., Inc. · Pathology
Mar 1993
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K930390 is an FDA 510(k) clearance for the 25 CM2, 75 CM2, 125 CM2 FLASK, CATALOG #03-291, a Cells, Animal And Human, Cultured (Class I — General Controls, product code KIR), submitted by Proteins Intl., Inc. (Rochester Hills, US). The FDA issued a Cleared decision on March 24, 1993, 57 days after receiving the submission on January 26, 1993. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K930390 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1993
Decision Date March 24, 1993
Days to Decision 57 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code KIR — Cells, Animal And Human, Cultured
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2280