Cleared Traditional

ROTACHROM HBPM/LMWH TEST KIT

K943516 · American Bioproducts Co. · Hematology
Aug 1995
Decision
406d
Days
Class 2
Risk

About This 510(k) Submission

K943516 is an FDA 510(k) clearance for the ROTACHROM HBPM/LMWH TEST KIT, a Assay, Heparin (Class II — Special Controls, product code KFF), submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on August 31, 1995, 406 days after receiving the submission on July 21, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7525.

Submission Details

510(k) Number K943516 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1994
Decision Date August 31, 1995
Days to Decision 406 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KFF — Assay, Heparin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7525

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