Cleared Traditional

PROVIAL II #006-010-0201

K823773 · Dynatech Corp. · Pathology
Jan 1983
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K823773 is an FDA 510(k) clearance for the PROVIAL II #006-010-0201, a Container, Specimen Mailer And Storage, Sterile (Class I — General Controls, product code KDT), submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1983, 38 days after receiving the submission on December 14, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3250.

Submission Details

510(k) Number K823773 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1982
Decision Date January 21, 1983
Days to Decision 38 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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