Cleared Traditional

RISTOCETIN COFACTOR ASSAY KIT

K945414 · Chrono-Log Corp. · Hematology
Jan 1995
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K945414 is an FDA 510(k) clearance for the RISTOCETIN COFACTOR ASSAY KIT, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on January 11, 1995, 65 days after receiving the submission on November 7, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K945414 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1994
Decision Date January 11, 1995
Days to Decision 65 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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