Cleared Traditional

N-ASSAY TIA PLASMINOGEN TEST KIT

K971985 · Crestat Diagnostics, Inc. · Hematology
Oct 1997
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K971985 is an FDA 510(k) clearance for the N-ASSAY TIA PLASMINOGEN TEST KIT, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Crestat Diagnostics, Inc. (Weston, US). The FDA issued a Cleared decision on October 20, 1997, 144 days after receiving the submission on May 29, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K971985 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1997
Decision Date October 20, 1997
Days to Decision 144 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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