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FDA 510(k)

ATAC 4300 HEMATOLOGY CELL COUNTER

K-Number: K863332 · 1986-09-29

ApplicantTurpen Laboratory Systems, Inc.
Decision Date1986-09-29
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ATAC 4300 HEMATOLOGY CELL COUNTER 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 1986-09-29 under 510(k) number K863332. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATAC 4300 HEMATOLOGY CELL COUNTER?

ATAC 4300 HEMATOLOGY CELL COUNTER is a medical device that received FDA 510(k) clearance on 1986-09-29. The listed applicant is Turpen Laboratory Systems, Inc.. The 510(k) number is K863332.

When did ATAC 4300 HEMATOLOGY CELL COUNTER receive FDA 510(k) clearance?

ATAC 4300 HEMATOLOGY CELL COUNTER received FDA 510(k) clearance on 1986-09-29, under 510(k) number K863332.

Who is the listed applicant for ATAC 4300 HEMATOLOGY CELL COUNTER?

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 4300 HEMATOLOGY CELL COUNTER?

The FDA product code for ATAC 4300 HEMATOLOGY CELL COUNTER is GKL.

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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 ANALYZERK851321ATAC 2000 CHEMISTRY ANALYZERK843059ATAC 2000K832115ATAC 3000K832116ATAC 4700 HEMATOLOGY CELL COUNTER

Related Devices (Code: GKL)

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.

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris DiagnosticsK071652HEMOCUE WBC SYSTEMHemocue ABK051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLCK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K032677SYSMEX POCH-100ISysmex America, Inc.

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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