Cleared Traditional

FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR

K862318 · Fisher Scientific Co., LLC · Hematology
Jul 1986
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K862318 is an FDA 510(k) clearance for the FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Fisher Scientific Co., LLC (Orangeburg, US). The FDA issued a Cleared decision on July 10, 1986, 22 days after receiving the submission on June 18, 1986. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K862318 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1986
Decision Date July 10, 1986
Days to Decision 22 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JPK — Mixture, Hematology Quality Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625