Cleared Traditional

SANGUI BIOTECH, INC. CALCITONIN ELISA KIT

K982491 · Sangui Biotech, Inc. · Chemistry
Sep 1998
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K982491 is an FDA 510(k) clearance for the SANGUI BIOTECH, INC. CALCITONIN ELISA KIT, a Radioimmunoassay, Calcitonin (Class II — Special Controls, product code JKR), submitted by Sangui Biotech, Inc. (Santa Ana, US). The FDA issued a Cleared decision on September 3, 1998, 48 days after receiving the submission on July 17, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1140.

Submission Details

510(k) Number K982491 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1998
Decision Date September 03, 1998
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JKR — Radioimmunoassay, Calcitonin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1140

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