Cleared Traditional

TIPSEP-CORTISOL RIA DIAGNOSTIC KIT

K872177 · Nuclear Diagnostics, Inc. · Chemistry
Jun 1987
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K872177 is an FDA 510(k) clearance for the TIPSEP-CORTISOL RIA DIAGNOSTIC KIT, a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR), submitted by Nuclear Diagnostics, Inc. (Troy, US). The FDA issued a Cleared decision on June 17, 1987, 9 days after receiving the submission on June 8, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K872177 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1987
Decision Date June 17, 1987
Days to Decision 9 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGR — Radioimmunoassay, Cortisol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1205

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