Cleared Traditional

ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS

K951071 · Alko Diagnostic Corp. · Hematology
Jul 1995
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K951071 is an FDA 510(k) clearance for the ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS, a Calibrator For Hemoglobin And Hematocrit Measurement (Class II — Special Controls, product code KRZ), submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on July 24, 1995, 138 days after receiving the submission on March 8, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8165.

Submission Details

510(k) Number K951071 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1995
Decision Date July 24, 1995
Days to Decision 138 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KRZ — Calibrator For Hemoglobin And Hematocrit Measurement
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8165

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