Cleared Traditional

CULTURETTE BRAND PVA

K790815 · Marion Laboratories, Inc. · Pathology
May 1979
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K790815 is an FDA 510(k) clearance for the CULTURETTE BRAND PVA, a Solution, Carnoy's (Class I — General Controls, product code IGM), submitted by Marion Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 15, 1979, 18 days after receiving the submission on April 27, 1979. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K790815 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1979
Decision Date May 15, 1979
Days to Decision 18 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IGM — Solution, Carnoy's
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010