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FDA 510(k)

MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX

K-Number: K864342 · 1986-12-01

ApplicantEiken Chemical Co., Inc.
Decision Date1986-12-01
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX is the device name listed in this FDA 510(k) record. The listed applicant is Eiken Chemical Co., Inc.. It received FDA 510(k) clearance on 1986-12-01 under 510(k) number K864342. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX?

MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX is a medical device that received FDA 510(k) clearance on 1986-12-01. The listed applicant is Eiken Chemical Co., Inc.. The 510(k) number is K864342.

When did MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX receive FDA 510(k) clearance?

MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX received FDA 510(k) clearance on 1986-12-01, under 510(k) number K864342.

Who is the listed applicant for MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX?

The FDA 510(k) record lists Eiken Chemical Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX?

The FDA product code for MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX is CFN.

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Other records listing Eiken Chemical Co., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K853391MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000

Related Devices (Code: CFN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbHK221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group , Ltd.K191985Optilite IgA KitThe Binding Site Group , Ltd.K191635Optilite IgM KitThe Binding Site Group , Ltd.K191465Human IgM Kit for use on SPAPlusThe Binding Site Group , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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