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FDA 510(k)

SYSTEM 8000 CELL COUNTER

K-Number: K850386 · 1985-05-02

ApplicantBaker Instructions Corp.
Decision Date1985-05-02
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSTEM 8000 CELL COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Baker Instructions Corp.. It received FDA 510(k) clearance on 1985-05-02 under 510(k) number K850386. 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 SYSTEM 8000 CELL COUNTER?

SYSTEM 8000 CELL COUNTER is a medical device that received FDA 510(k) clearance on 1985-05-02. The listed applicant is Baker Instructions Corp.. The 510(k) number is K850386.

When did SYSTEM 8000 CELL COUNTER receive FDA 510(k) clearance?

SYSTEM 8000 CELL COUNTER received FDA 510(k) clearance on 1985-05-02, under 510(k) number K850386.

Who is the listed applicant for SYSTEM 8000 CELL COUNTER?

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

What is the FDA product code for SYSTEM 8000 CELL COUNTER?

The FDA product code for SYSTEM 8000 CELL COUNTER is GKL.

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Other records listing Baker Instructions Corp. 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.

K882612SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTERK873596BAKER TDM THEOPHYLLINE ASSAYK870603SYSTEM 9000 AUTOMATED CELL COUNTERK854173UCD URINE SPECIMEN COLLECTORK833116SPIRIT CHEMISTRY SYSTEMK832716ENCORE CHEMISTRY ANALYZER

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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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