Cleared Traditional

CHIRON DIAGNOSTICS ACS:180TU P

K970539 · Chiron Diagnostics Corp. · Chemistry
Mar 1997
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K970539 is an FDA 510(k) clearance for the CHIRON DIAGNOSTICS ACS:180TU P, a Radioassay, Triiodothyronine Uptake (Class II — Special Controls, product code KHQ), submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on March 24, 1997, 40 days after receiving the submission on February 12, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1715.

Submission Details

510(k) Number K970539 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1997
Decision Date March 24, 1997
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHQ — Radioassay, Triiodothyronine Uptake
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1715

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