Cleared Traditional

CHROMOLIZE TPA ASSAY KIT

K962489 · Medical Diagnostic Technologies, Inc. · Hematology
Jul 1996
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K962489 is an FDA 510(k) clearance for the CHROMOLIZE TPA ASSAY 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 July 31, 1996, 35 days after receiving the submission on June 26, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K962489 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1996
Decision Date July 31, 1996
Days to Decision 35 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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