Cleared Traditional

IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT

K894049 · Pantex, Div. Bio-Analysis, Inc. · Chemistry
Sep 1989
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K894049 is an FDA 510(k) clearance for the IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT, a Radioimmunoassay, Progesterone (Class I — General Controls, product code JLS), submitted by Pantex, Div. Bio-Analysis, Inc. (Santa Monica, US). The FDA issued a Cleared decision on September 8, 1989, 93 days after receiving the submission on June 7, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1620.

Submission Details

510(k) Number K894049 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 1989
Decision Date September 08, 1989
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

Similar Devices — JLS Radioimmunoassay, Progesterone

All 56
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
K040923 · Ibl GmbH · Jul 2004
PROGESTERONE ELISA
K973898 · Kmi Diagnostics, Inc. · Nov 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
K972133 · Johnson & Johnson Clinical Diagnostics, Inc. · Jun 1997
OPUS PROGESTERONE
K971725 · Behring Diagnostics, Inc. · Jun 1997
ELECSYS PROGESTERONE ASSAY
K964841 · Boehringer Mannheim Corp. · Mar 1997
VIDAS PROESTERONE (PRG) (30 409)
K965084 · bioMerieux, Inc. · Jan 1997