Cleared Traditional

CYTOQUANT(TM) MDCK CANINE KIDNEY CELLS

K930325 · Proteins Intl., Inc. · Pathology
Mar 1993
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K930325 is an FDA 510(k) clearance for the CYTOQUANT(TM) MDCK CANINE KIDNEY CELLS, 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 23, 1993, 60 days after receiving the submission on January 22, 1993. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K930325 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1993
Decision Date March 23, 1993
Days to Decision 60 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