Cleared Traditional

NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT

K911839 · Pantex, Div. Bio-Analysis, Inc. · Chemistry
Jun 1991
Decision
54d
Days
Class 1
Risk

About This 510(k) Submission

K911839 is an FDA 510(k) clearance for the NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT, a Radioimmunoassay, 17-hydroxyprogesterone (Class I — General Controls, product code JLX), submitted by Pantex, Div. Bio-Analysis, Inc. (Santa Monica, US). The FDA issued a Cleared decision on June 18, 1991, 54 days after receiving the submission on April 25, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1395.

Submission Details

510(k) Number K911839 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1991
Decision Date June 18, 1991
Days to Decision 54 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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