Cleared Traditional

TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY

K972666 · Hybritech, Inc. · Chemistry
Sep 1997
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K972666 is an FDA 510(k) clearance for the TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY, a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II — Special Controls, product code CIN), submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on September 11, 1997, 57 days after receiving the submission on July 16, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K972666 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1997
Decision Date September 11, 1997
Days to Decision 57 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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