Cleared Traditional

SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT

K982608 · Sangui Biotech, Inc. · Chemistry
Aug 1998
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K982608 is an FDA 510(k) clearance for the SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT, a Radioimmunoassay, Acth (Class II — Special Controls, product code CKG), submitted by Sangui Biotech, Inc. (Santa Ana, US). The FDA issued a Cleared decision on August 19, 1998, 23 days after receiving the submission on July 27, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1025.

Submission Details

510(k) Number K982608 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1998
Decision Date August 19, 1998
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CKG — Radioimmunoassay, Acth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1025

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