Cleared Traditional

CHROMOLIZE PAI-1 KIT

K963106 · Medical Diagnostic Technologies, Inc. · Hematology
Nov 1996
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K963106 is an FDA 510(k) clearance for the CHROMOLIZE PAI-1 KIT, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on November 18, 1996, 98 days after receiving the submission on August 12, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K963106 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1996
Decision Date November 18, 1996
Days to Decision 98 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GGP — Test, Qualitative And Quantitative Factor Deficiency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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