Cleared Traditional

BIOCLOT PROTEIN S

K955738 · Medical Diagnostic Technologies, Inc. · Hematology
Feb 1996
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K955738 is an FDA 510(k) clearance for the BIOCLOT PROTEIN S, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on February 29, 1996, 76 days after receiving the submission on December 15, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K955738 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 1995
Decision Date February 29, 1996
Days to Decision 76 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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