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FDA 510(k)

MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000

K-Number: K853391 · 1985-10-01

ApplicantEiken Chemical Co., Inc.
Decision Date1985-10-01
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000 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 1985-10-01 under 510(k) number K853391. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000?

MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000 is a medical device that received FDA 510(k) clearance on 1985-10-01. The listed applicant is Eiken Chemical Co., Inc.. The 510(k) number is K853391.

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

MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000 received FDA 510(k) clearance on 1985-10-01, under 510(k) number K853391.

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

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 SYS-LA-2000?

The FDA product code for MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000 is JJE.

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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.

K864342MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX

Related Devices (Code: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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