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FDA 510(k)

ATAC 6000 CHEMISTRY ANALYZER

K-Number: K924084 · 1992-09-29

ApplicantBio-Chem Laboratory Systems, Inc.
Decision Date1992-09-29
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC 6000 CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Chem Laboratory Systems, Inc.. It received FDA 510(k) clearance on 1992-09-29 under 510(k) number K924084. 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 ATAC 6000 CHEMISTRY ANALYZER?

ATAC 6000 CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1992-09-29. The listed applicant is Bio-Chem Laboratory Systems, Inc.. The 510(k) number is K924084.

When did ATAC 6000 CHEMISTRY ANALYZER receive FDA 510(k) clearance?

ATAC 6000 CHEMISTRY ANALYZER received FDA 510(k) clearance on 1992-09-29, under 510(k) number K924084.

Who is the listed applicant for ATAC 6000 CHEMISTRY ANALYZER?

The FDA 510(k) record lists Bio-Chem Laboratory Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATAC 6000 CHEMISTRY ANALYZER?

The FDA product code for ATAC 6000 CHEMISTRY ANALYZER is JJE.

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Other records listing Bio-Chem Laboratory Systems, 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.

K945271ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEMK930689AUTOBEAD THYROID UPTAKEK930006AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KITK926563AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT

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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