Cleared Traditional

TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES

K871483 · Isratech Marketing Corp. · Pathology
Apr 1987
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K871483 is an FDA 510(k) clearance for the TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES, a Dish, Tissue Culture (Class I — General Controls, product code KIZ), submitted by Isratech Marketing Corp. (New York, US). The FDA issued a Cleared decision on April 29, 1987, 14 days after receiving the submission on April 15, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.

Submission Details

510(k) Number K871483 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1987
Decision Date April 29, 1987
Days to Decision 14 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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