Cleared Traditional

HUMAN IGD IMMUNOLOGICAL NL TEST KIT

K913671 · The Binding Site, Ltd. · Immunology
Dec 1991
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K913671 is an FDA 510(k) clearance for the HUMAN IGD IMMUNOLOGICAL NL TEST KIT, a Igd, Antigen, Antiserum, Control (Class II — Special Controls, product code CZJ), submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on December 2, 1991, 105 days after receiving the submission on August 19, 1991. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K913671 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1991
Decision Date December 02, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code CZJ — Igd, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

Similar Devices — CZJ Igd, Antigen, Antiserum, Control

All 7
HUMAN IGD KIT FOR USE ON SPAPLUS
K092450 · The Binding Site · Dec 2009
IGD DIAGNOSTIC TEST KITS
K051299 · The Binding Site, Ltd. · Nov 2005
SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT
K002561 · The Binding Site, Ltd. · Oct 2000
QM300 CALIBRATOR D PACK
K883001 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1988
TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410
K872834 · Helena Laboratories · Aug 1987
DETERM. SIZE 72 RADIAL-HUMAN IGD
K831956 · Kent Laboratories, Inc. · Jul 1983