Cleared Traditional

BC THROMBIN REAGENT

K970645 · Behring Diagnostics, Inc. · Hematology
May 1997
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K970645 is an FDA 510(k) clearance for the BC THROMBIN REAGENT, a Test, Thrombin Time (Class II — Special Controls, product code GJA), submitted by Behring Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on May 19, 1997, 88 days after receiving the submission on February 20, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7875.

Submission Details

510(k) Number K970645 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 1997
Decision Date May 19, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

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

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