Cleared Traditional

AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086

K914135 · Amersham Corp. · Chemistry
Feb 1992
Decision
155d
Days
Class 1
Risk

About This 510(k) Submission

K914135 is an FDA 510(k) clearance for the AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086, a Radioimmunoassay, Prolactin (lactogen) (Class I — General Controls, product code CFT), submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on February 18, 1992, 155 days after receiving the submission on September 16, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number K914135 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 1991
Decision Date February 18, 1992
Days to Decision 155 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CFT — Radioimmunoassay, Prolactin (lactogen)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1625

Similar Devices — CFT Radioimmunoassay, Prolactin (lactogen)

All 79
PROLACTIN (PRL) HORMONE MICROPLATE ELISA
K971921 · Monobind · Jun 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
K970281 · Johnson & Johnson Clinical Diagnostics, Inc. · Feb 1997
SEALITE SCIENCES, INC. AQUALITE PROLACTIN
K970188 · Sealite Sciences, Inc. · Feb 1997
ELECSYS PROLACTIN ASSAY
K964748 · Boehringer Mannheim Corp. · Jan 1997
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
K960561 · Diagnostic Systems Laboratories, Inc. · Apr 1996
DSL ACTIVE PROLACTIN IRMA
K960060 · Diagnostic Systems Laboratories, Inc. · Feb 1996