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FDA 510(k)

ASSIST CLINICAL CHEMISTRY ANALYZER

K-Number: K852262 · 1985-06-25

ApplicantCooper Biomedical, Inc.
Decision Date1985-06-25
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASSIST CLINICAL CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Biomedical, Inc.. It received FDA 510(k) clearance on 1985-06-25 under 510(k) number K852262. 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 ASSIST CLINICAL CHEMISTRY ANALYZER?

ASSIST CLINICAL CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1985-06-25. The listed applicant is Cooper Biomedical, Inc.. The 510(k) number is K852262.

When did ASSIST CLINICAL CHEMISTRY ANALYZER receive FDA 510(k) clearance?

ASSIST CLINICAL CHEMISTRY ANALYZER received FDA 510(k) clearance on 1985-06-25, under 510(k) number K852262.

Who is the listed applicant for ASSIST CLINICAL CHEMISTRY ANALYZER?

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

What is the FDA product code for ASSIST CLINICAL CHEMISTRY ANALYZER?

The FDA product code for ASSIST CLINICAL CHEMISTRY ANALYZER is JJE.

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Other records listing Cooper Biomedical, 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.

K863868IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANTK864512IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTOK863301DEMAND TOTAL PROTEINK861926WORTHINGTON HDL PRECIPITATING REAGENT SETK854130DEMAND ETHYL ALCOHOLK853949DEMAND ACID PHOSPHATASE REAGENT

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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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