Cleared Traditional

ACCESS OSTASE IMMUNOENZYMETRIC ASSAY

K994278 · Beckman Coulter, Inc. · Chemistry
Mar 2000
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K994278 is an FDA 510(k) clearance for the ACCESS OSTASE IMMUNOENZYMETRIC ASSAY, a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II — Special Controls, product code CIN), submitted by Beckman Coulter, Inc. (San Diego, US). The FDA issued a Cleared decision on March 28, 2000, 99 days after receiving the submission on December 20, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K994278 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1999
Decision Date March 28, 2000
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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