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FDA 510(k)

COMPU-CHEM II CHEMISTRY ANALYZER

K-Number: K802835 · 1980-12-11

ApplicantDiagnostic Aids, Inc.
Decision Date1980-12-11
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COMPU-CHEM II CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Aids, Inc.. It received FDA 510(k) clearance on 1980-12-11 under 510(k) number K802835. 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 COMPU-CHEM II CHEMISTRY ANALYZER?

COMPU-CHEM II CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Diagnostic Aids, Inc.. The 510(k) number is K802835.

When did COMPU-CHEM II CHEMISTRY ANALYZER receive FDA 510(k) clearance?

COMPU-CHEM II CHEMISTRY ANALYZER received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802835.

Who is the listed applicant for COMPU-CHEM II CHEMISTRY ANALYZER?

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

What is the FDA product code for COMPU-CHEM II CHEMISTRY ANALYZER?

The FDA product code for COMPU-CHEM II CHEMISTRY ANALYZER is JJE.

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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

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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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