Cleared Traditional

120 WELL HISTO-PLATE

K790958 · Dynatech Laboratories, Inc. · Pathology
Jun 1979
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K790958 is an FDA 510(k) clearance for the 120 WELL HISTO-PLATE, a Dish, Tissue Culture (Class I — General Controls, product code KIZ), submitted by Dynatech Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1979, 37 days after receiving the submission on May 22, 1979. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.

Submission Details

510(k) Number K790958 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1979
Decision Date June 28, 1979
Days to Decision 37 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KIZ — Dish, Tissue Culture
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2240

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