Cleared Traditional

SACCOMANNO SPECIMAN SOLUTION

K862725 · Mill-Rose Laboratory · Pathology
Aug 1986
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K862725 is an FDA 510(k) clearance for the SACCOMANNO SPECIMAN SOLUTION, a Fixative, Alcohol Containing (Class I — General Controls, product code LDZ), submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on August 1, 1986, 15 days after receiving the submission on July 17, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K862725 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1986
Decision Date August 01, 1986
Days to Decision 15 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code LDZ — Fixative, Alcohol Containing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010

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