Max L System

FDA 510(k) K761168 · Brinkman Instruments, Inc.

Substantially Equivalent

510(k) numberK761168

Submission

Device name
Max L System
Applicant
Brinkman Instruments, Inc.
Mchenry, IL, US
Received
December 1, 1976
Decision date
December 10, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DPM – Columns, Liquid Chromatography
Device class
Class I (low risk)
Regulation
21 CFR 862.2260
Specialty
Clinical Chemistry

Other 510(k)s with product code DPM

510(k)DeviceApplicantDecision
K952501Tox Perfect B Tubes and ReagentsDPM · Traditional Chimera Research & Chemical, Inc.08/24/1995SE
K895105High Pressure Inert Plastic Columns for Clin. UseDPM · Traditional Waters Chemical Products10/06/1989SE
K894141Liquid Chromatography ColumnsDPM · Traditional Supelco, Inc.08/21/1989SE
K891673Advanced Purification Glass ColumnDPM · Traditional Waters Chemical Products04/26/1989SE
K884403Liquid Chromatography Columns Solid Phase Ex. TubeDPM · Traditional Supelco, Inc.12/22/1988SE
K881868Liquid Chromatography Columns Hisep Column & GuardDPM · Traditional Supelco, Inc.08/29/1988SE
K880724Liquid Chromato. ColumnsDPM · Traditional Supelco, Inc.05/27/1988SE
K864267Sep-Pak Cartridges (Liquid Chromatography)DPM · Traditional Millipore Corp.01/09/1987SE
K862541Liquid Chromatography ColumnsDPM · Traditional Supelco, Inc.07/29/1986SE
K861633Liquid Chromatography ColumnsDPM · Traditional Supelco, Inc.05/23/1986SE

Questions and answers

When was Max L System cleared by the FDA?

Max L System (K761168) received a 510(k) decision of Substantially Equivalent on December 10, 1976, 9 days after the submission was received.

What is the product code of K761168?

The FDA product code is DPM – Columns, Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.