Cleared Traditional

K771925 - KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP
(FDA 510(k) Clearance)

Nov 1977
Decision
19d
Days
Class 1
Risk

K771925 is an FDA 510(k) clearance for the KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP. This device is classified as a Coverslips, Microscope Slide (Class I - General Controls, product code KES).

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on November 2, 1977, 19 days after receiving the submission on October 14, 1977.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K771925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1977
Decision Date November 02, 1977
Days to Decision 19 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary

Device Classification

Product Code KES — Coverslips, Microscope Slide
Device Class Class I - General Controls
CFR Regulation 21 CFR 864.3010