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FDA 510(k)

ATAC 3000

K-Number: K832115 · 1984-01-10

ApplicantTurpen Laboratory Systems, Inc.
Decision Date1984-01-10
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Turpen Laboratory Systems, Inc.. It received FDA 510(k) clearance on 1984-01-10 under 510(k) number K832115. 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 3000?

ATAC 3000 is a medical device that received FDA 510(k) clearance on 1984-01-10. The listed applicant is Turpen Laboratory Systems, Inc.. The 510(k) number is K832115.

When did ATAC 3000 receive FDA 510(k) clearance?

ATAC 3000 received FDA 510(k) clearance on 1984-01-10, under 510(k) number K832115.

Who is the listed applicant for ATAC 3000?

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

What is the FDA product code for ATAC 3000?

The FDA product code for ATAC 3000 is JJE.

Other records listing Turpen 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.

K870836ATAC 1500 CHEMISTRY ANALYZERK863332ATAC 4300 HEMATOLOGY CELL COUNTERK851321ATAC 2000 CHEMISTRY ANALYZERK843059ATAC 2000K832116ATAC 4700 HEMATOLOGY CELL COUNTER

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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