Cleared Traditional

ASSERACHROM FREE PROTEIN S KIT

K954017 · American Bioproducts Co. · Hematology
Nov 1995
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K954017 is an FDA 510(k) clearance for the ASSERACHROM FREE PROTEIN S KIT, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on November 13, 1995, 80 days after receiving the submission on August 25, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K954017 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 1995
Decision Date November 13, 1995
Days to Decision 80 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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