Cleared Traditional

ACCUSCREEN 17-HYDROXYPROGESTERONE

K934178 · Neometrics, Inc. · Chemistry
Mar 1995
Decision
580d
Days
Class 1
Risk

About This 510(k) Submission

K934178 is an FDA 510(k) clearance for the ACCUSCREEN 17-HYDROXYPROGESTERONE, a Radioimmunoassay, 17-hydroxyprogesterone (Class I — General Controls, product code JLX), submitted by Neometrics, Inc. (E. Northport, US). The FDA issued a Cleared decision on March 30, 1995, 580 days after receiving the submission on August 27, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1395.

Submission Details

510(k) Number K934178 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1993
Decision Date March 30, 1995
Days to Decision 580 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JLX — Radioimmunoassay, 17-hydroxyprogesterone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1395

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