Cleared Traditional

FRESH CELLS WI-38

K973212 · Diagnostic Hybrids, Inc. · Microbiology
Sep 1997
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K973212 is an FDA 510(k) clearance for the FRESH CELLS WI-38, 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 K973212 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

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