Cleared Traditional

BACTIDROP CALCOFLUOR WHITE

K920975 · Remel Co. · Pathology
Jun 1992
Decision
99d
Days
Class 1
Risk

About This 510(k) Submission

K920975 is an FDA 510(k) clearance for the BACTIDROP CALCOFLUOR WHITE, a Stains, Microbiologic (Class I — General Controls, product code JTS), submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on June 9, 1992, 99 days after receiving the submission on March 2, 1992. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K920975 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 1992
Decision Date June 09, 1992
Days to Decision 99 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement

Device Classification

Product Code JTS — Stains, Microbiologic
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850