Cleared Traditional

TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY

K930810 · Hybritech, Inc. · Chemistry
Jan 1994
Decision
328d
Days
Class 2
Risk

About This 510(k) Submission

K930810 is an FDA 510(k) clearance for the TANDEM-R OSTASE IMMUNORADIOMETRIC 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 January 11, 1994, 328 days after receiving the submission on February 17, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K930810 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 1993
Decision Date January 11, 1994
Days to Decision 328 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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