Cleared Traditional

THROMBIN CLOTTING TIME

K811109 · Bio/Data Corp. · Hematology
Jul 1981
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K811109 is an FDA 510(k) clearance for the THROMBIN CLOTTING TIME, a Test, Thrombin Time (Class II — Special Controls, product code GJA), submitted by Bio/Data Corp. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981, 84 days after receiving the submission on April 23, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7875.

Submission Details

510(k) Number K811109 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 1981
Decision Date July 16, 1981
Days to Decision 84 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GJA — Test, Thrombin Time
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7875

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