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FDA 510(k)

AUTOMATED IMMUOCHEMISTRY SYSTEM

K-Number: K803267 · 1981-01-16

ApplicantBeckman Instruments, Inc.
Decision Date1981-01-16
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTOMATED IMMUOCHEMISTRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1981-01-16 under 510(k) number K803267. 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 AUTOMATED IMMUOCHEMISTRY SYSTEM?

AUTOMATED IMMUOCHEMISTRY SYSTEM is a medical device that received FDA 510(k) clearance on 1981-01-16. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K803267.

When did AUTOMATED IMMUOCHEMISTRY SYSTEM receive FDA 510(k) clearance?

AUTOMATED IMMUOCHEMISTRY SYSTEM received FDA 510(k) clearance on 1981-01-16, under 510(k) number K803267.

Who is the listed applicant for AUTOMATED IMMUOCHEMISTRY SYSTEM?

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

What is the FDA product code for AUTOMATED IMMUOCHEMISTRY SYSTEM?

The FDA product code for AUTOMATED IMMUOCHEMISTRY SYSTEM is JJE.

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Other records listing Beckman Instruments, 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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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

View on FDA Database →

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

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