Multipurpose Immunochemistry System LA-2000 Latex

FDA 510(k) K864342 · Eiken Chemical Co., Inc.

Substantially Equivalent

510(k) numberK864342

Submission

Device name
Multipurpose Immunochemistry System LA-2000 Latex
Applicant
Eiken Chemical Co., Inc.
Venice, CA, US
Received
November 4, 1986
Decision date
December 1, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CFN – Method, Nephelometric, Immunoglobulins (G, A, M)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Specialty
Immunology

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Questions and answers

When was Multipurpose Immunochemistry System LA-2000 Latex cleared by the FDA?

Multipurpose Immunochemistry System LA-2000 Latex (K864342) received a 510(k) decision of Substantially Equivalent on December 1, 1986, 27 days after the submission was received.

What is the product code of K864342?

The FDA product code is CFN – Method, Nephelometric, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.