Cleared Traditional

THROMBINEX BOVINE THROMBIN

K845000 · Bio/Data Corp. · Hematology
Mar 1985
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K845000 is an FDA 510(k) clearance for the THROMBINEX BOVINE THROMBIN, a Test, Thrombin Time (Class II — Special Controls, product code GJA), submitted by Bio/Data Corp. (Hatboro, US). The FDA issued a Cleared decision on March 26, 1985, 90 days after receiving the submission on December 26, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7875.

Submission Details

510(k) Number K845000 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 1984
Decision Date March 26, 1985
Days to Decision 90 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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