Cleared Traditional

MSI-CAL 7

K883703 · Medical Specialties, Inc. · Hematology
Nov 1988
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K883703 is an FDA 510(k) clearance for the MSI-CAL 7, a Calibrator For Hemoglobin And Hematocrit Measurement (Class II — Special Controls, product code KRZ), submitted by Medical Specialties, Inc. (South Plainfield, US). The FDA issued a Cleared decision on November 22, 1988, 84 days after receiving the submission on August 30, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8165.

Submission Details

510(k) Number K883703 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1988
Decision Date November 22, 1988
Days to Decision 84 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

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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