Cleared Traditional

ALKPHASE-B ASSAY KIT

K981373 · Metra Biosystems, Inc. · Chemistry
May 1998
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K981373 is an FDA 510(k) clearance for the ALKPHASE-B ASSAY KIT, a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II — Special Controls, product code CIN), submitted by Metra Biosystems, Inc. (Mountain View, US). The FDA issued a Cleared decision on May 27, 1998, 41 days after receiving the submission on April 16, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K981373 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 1998
Decision Date May 27, 1998
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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