Cleared Traditional

MSI-HCT

K924926 · Medical Specialties, Inc. · Hematology
Jan 1993
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K924926 is an FDA 510(k) clearance for the MSI-HCT, a Control, Hematocrit (Class II — Special Controls, product code GLK), submitted by Medical Specialties, Inc. (South Plainfield, US). The FDA issued a Cleared decision on January 7, 1993, 99 days after receiving the submission on September 30, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K924926 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1992
Decision Date January 07, 1993
Days to Decision 99 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GLK — Control, Hematocrit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625

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