Cleared Traditional

PRESERV PVA FIXATIVE -MALIN PACK

K833660 · Preventive Diagnostics Corp. · Microbiology
Nov 1983
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K833660 is an FDA 510(k) clearance for the PRESERV PVA FIXATIVE -MALIN PACK, a Container, Specimen Mailer And Storage, Sterile (Class I — General Controls, product code KDT), submitted by Preventive Diagnostics Corp. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983, 41 days after receiving the submission on October 18, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.3250.

Submission Details

510(k) Number K833660 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 1983
Decision Date November 28, 1983
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code KDT — Container, Specimen Mailer And Storage, Sterile
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3250

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