Cleared Traditional

STA-LIATEST FREE PROTEIN S TEST KIT

K010963 · Diagnostica Stago, Inc. · Hematology
Jun 2001
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K010963 is an FDA 510(k) clearance for the STA-LIATEST FREE PROTEIN S TEST KIT, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Diagnostica Stago, Inc. (Parisppany, US). The FDA issued a Cleared decision on June 6, 2001, 68 days after receiving the submission on March 30, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K010963 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2001
Decision Date June 06, 2001
Days to Decision 68 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

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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