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FDA 510(k)

HEMATOLOGY ANALYZER

K-Number: K823344 · 1982-12-28

ApplicantAbbott Diagnostics
Decision Date1982-12-28
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATOLOGY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K823344. 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 HEMATOLOGY ANALYZER?

HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Abbott Diagnostics. The 510(k) number is K823344.

When did HEMATOLOGY ANALYZER receive FDA 510(k) clearance?

HEMATOLOGY ANALYZER received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823344.

Who is the listed applicant for HEMATOLOGY ANALYZER?

The FDA 510(k) record lists Abbott Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMATOLOGY ANALYZER?

The FDA product code for HEMATOLOGY ANALYZER is GKL.

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Other records listing Abbott Diagnostics 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.

K964185IMX CA 125K972182ABBOTT STREP A CONTROLSK961439ABBOTT CELL-DYN 4000 SYSTEMK890491CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYERK881242CELL-DYN RAPID-LYSE AND HEMOGLOBLINK881130CELL-DYN ISOTONIC DILUENT

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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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