Cleared Traditional

FRESH CELLS VERO

K973209 · Diagnostic Hybrids, Inc. · Microbiology
Sep 1997
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K973209 is an FDA 510(k) clearance for the FRESH CELLS VERO, a Cells, Animal And Human, Cultured (Class I — General Controls, product code KIR), submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on September 25, 1997, 29 days after receiving the submission on August 27, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K973209 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1997
Decision Date September 25, 1997
Days to Decision 29 days
Submission Type Traditional
Review Panel Microbiology (MI)
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

Similar Devices — KIR Cells, Animal And Human, Cultured

All 169
FRESH CELLS NCI H292
K973210 · Diagnostic Hybrids, Inc. · Sep 1997
FRESH CELLS MV1LU
K973211 · Diagnostic Hybrids, Inc. · Sep 1997
FRESH CELLS WI-38
K973212 · Diagnostic Hybrids, Inc. · Sep 1997
FRESH CELLS LLC-MK2
K973213 · Diagnostic Hybrids, Inc. · Sep 1997
FRESH CELLS HFF
K973214 · Diagnostic Hybrids, Inc. · Sep 1997
RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE
K971508 · Bio-Whittaker, Inc., A Cambrex Co. · Sep 1997