Cleared Traditional

AXSYM PROGESTERONE

K955025 · Abbott Laboratories · Chemistry
Mar 1996
Decision
126d
Days
Class 1
Risk

About This 510(k) Submission

K955025 is an FDA 510(k) clearance for the AXSYM PROGESTERONE, a Radioimmunoassay, Progesterone (Class I — General Controls, product code JLS), submitted by Abbott Laboratories (Buffalo, US). The FDA issued a Cleared decision on March 7, 1996, 126 days after receiving the submission on November 2, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1620.

Submission Details

510(k) Number K955025 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1995
Decision Date March 07, 1996
Days to Decision 126 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JLS — Radioimmunoassay, Progesterone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1620

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