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FDA 510(k)

ATAC 4700 HEMATOLOGY CELL COUNTER

K-Number: K832116 · 1983-10-20

ApplicantTurpen Laboratory Systems, Inc.
Decision Date1983-10-20
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ATAC 4700 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 1983-10-20 under 510(k) number K832116. The device is classified under product code GIF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATAC 4700 HEMATOLOGY CELL COUNTER?

ATAC 4700 HEMATOLOGY CELL COUNTER is a medical device that received FDA 510(k) clearance on 1983-10-20. The listed applicant is Turpen Laboratory Systems, Inc.. The 510(k) number is K832116.

When did ATAC 4700 HEMATOLOGY CELL COUNTER receive FDA 510(k) clearance?

ATAC 4700 HEMATOLOGY CELL COUNTER received FDA 510(k) clearance on 1983-10-20, under 510(k) number K832116.

Who is the listed applicant for ATAC 4700 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 4700 HEMATOLOGY CELL COUNTER?

The FDA product code for ATAC 4700 HEMATOLOGY CELL COUNTER is GIF.

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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 ANALYZERK863332ATAC 4300 HEMATOLOGY CELL COUNTERK851321ATAC 2000 CHEMISTRY ANALYZERK843059ATAC 2000K832115ATAC 3000

Related Devices (Code: GIF)

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.

K883989KVM ISOTONIC FLUSH SOLUTIONKvm Technologies, Inc.K883990KVM ISOTONIC DILUENTKvm Technologies, Inc.K882490HYCEL QUICK-LYSING HEMOGLOBIN REAGENTR&D Systems, Inc.K882267SYSMEX QUICKLYSER-II (QLS-200A)Toa Medical Electronics USA, Inc.K881130CELL-DYN ISOTONIC DILUENTAbbott DiagnosticsK873347CELL-DYN DIFF. SCREEN ISOTONIC DILUENTAbbott 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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