Cleared Traditional

COBAS INTEGRA REAGENT CASSETTES

K982382 · Roche Diagnostic Systems, Inc. · Immunology
Sep 1998
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K982382 is an FDA 510(k) clearance for the COBAS INTEGRA REAGENT CASSETTES, a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFN), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on September 28, 1998, 82 days after receiving the submission on July 8, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K982382 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1998
Decision Date September 28, 1998
Days to Decision 82 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code CFN — Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

Similar Devices — CFN Method, Nephelometric, Immunoglobulins (g, A, M)

All 60
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
K233663 · Siemens Healthcare Diagnostics Products GmbH · Dec 2023
Immunoglobulin G (IgG)
K221114 · Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · Aug 2023
Human IgA liquid reagent kit for Use on SPAPlus
K192116 · The Binding Site Group , Ltd. · Sep 2019
Optilite IgA Kit
K191985 · The Binding Site Group , Ltd. · Aug 2019
Optilite IgM Kit
K191635 · The Binding Site Group , Ltd. · Jul 2019
Human IgM Kit for use on SPAPlus
K191465 · The Binding Site Group , Ltd. · Jun 2019