Cleared Traditional

STAR AUTOMATED MULTI-PARAMETRIC ANALYZER

K983460 · American Bioproducts Co. · Hematology
Nov 1998
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K983460 is an FDA 510(k) clearance for the STAR AUTOMATED MULTI-PARAMETRIC ANALYZER, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on November 12, 1998, 43 days after receiving the submission on September 30, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K983460 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1998
Decision Date November 12, 1998
Days to Decision 43 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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