Cleared Traditional

ASSERACHROM TOTAL PROTEIN S KIT

K954040 · American Bioproducts Co. · Hematology
Nov 1995
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K954040 is an FDA 510(k) clearance for the ASSERACHROM TOTAL 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, 77 days after receiving the submission on August 28, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K954040 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 1995
Decision Date November 13, 1995
Days to Decision 77 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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