Cleared Traditional

IGA MININEPH ANTISERUM

K981786 · The Binding Site, Ltd. · Immunology
Nov 1999
Decision
553d
Days
Class 2
Risk

About This 510(k) Submission

K981786 is an FDA 510(k) clearance for the IGA MININEPH ANTISERUM, a Radioimmunoassay, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFQ), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on November 24, 1999, 553 days after receiving the submission on May 20, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K981786 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1998
Decision Date November 24, 1999
Days to Decision 553 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code CFQ — Radioimmunoassay, Immunoglobulins (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

Similar Devices — CFQ Radioimmunoassay, Immunoglobulins (g, A, M)

All 11
IGG FLEX REAGENT CARTRIDGE
K990551 · Dade Behring, Inc. · Mar 1999
IMMUNOGLOBULIN A TEST SYSTEM
K990552 · Dade Behring, Inc. · Mar 1999
IGM FLEX REAGENT CARTRIDGE
K990553 · Dade Behring, Inc. · Mar 1999
OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT
K951013 · Olympus America, Inc. · Apr 1995
OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT
K951055 · Olympus America, Inc. · Apr 1995
OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT
K950900 · Olympus America, Inc. · Mar 1995