Cleared Traditional

PREFILLED SPECIMEN CONTAINER

K820246 · Sage Products, Inc. · Pathology
Feb 1982
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K820246 is an FDA 510(k) clearance for the PREFILLED SPECIMEN CONTAINER, a Container, Specimen Mailer And Storage, Sterile (Class I — General Controls, product code KDT), submitted by Sage Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 18, 1982, 20 days after receiving the submission on January 29, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3250.

Submission Details

510(k) Number K820246 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1982
Decision Date February 18, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Pathology (PA)
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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