Cleared Traditional

PROC APC ASSAY, PROC CONTROL PLASMA

K962968 · Behring Diagnostics, Inc. · Hematology
Dec 1996
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K962968 is an FDA 510(k) clearance for the PROC APC ASSAY, PROC CONTROL PLASMA, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Behring Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on December 13, 1996, 136 days after receiving the submission on July 30, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K962968 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 1996
Decision Date December 13, 1996
Days to Decision 136 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

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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