Cleared Traditional

CALCOFLUOR WHITE STAIN KIT

K960090 · Remel Co. · Microbiology
Mar 1996
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K960090 is an FDA 510(k) clearance for the CALCOFLUOR WHITE STAIN KIT, a Stains, Microbiologic (Class I — General Controls, product code JTS), submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on March 19, 1996, 68 days after receiving the submission on January 11, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K960090 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 1996
Decision Date March 19, 1996
Days to Decision 68 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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