Cleared Traditional

STAINS, COUNTERSTAINS & GEN. PURPOSE

K792483 · Laboratory Products, Inc. · Pathology
Dec 1979
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K792483 is an FDA 510(k) clearance for the STAINS, COUNTERSTAINS & GEN. PURPOSE, a Carbol Fuchsin (Class I — General Controls, product code ICL), submitted by Laboratory Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1979, 29 days after receiving the submission on November 19, 1979. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K792483 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1979
Decision Date December 18, 1979
Days to Decision 29 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code ICL — Carbol Fuchsin
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850