Cleared Traditional

K860795 - SPOTTEST CALCOFLUOR WHITE REAGENT
(FDA 510(k) Clearance)

K860795 · Difco Laboratories, Inc. · Pathology
Mar 1986
Decision
8d
Days
Class 1
Risk

K860795 is an FDA 510(k) clearance for the SPOTTEST CALCOFLUOR WHITE REAGENT, a Stains, Chemical Solution (Class I — General Controls, product code LED), submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on March 12, 1986, 8 days after receiving the submission on March 4, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K860795 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 1986
Decision Date March 12, 1986
Days to Decision 8 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code LED — Stains, Chemical Solution
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850