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FDA 510(k)

ROYCO MODEL 921 CELL COUNTER

K-Number: K791867 · 1979-11-05

ApplicantRoyco Instruments
Decision Date1979-11-05
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ROYCO MODEL 921 CELL COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Royco Instruments. It received FDA 510(k) clearance on 1979-11-05 under 510(k) number K791867. 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 ROYCO MODEL 921 CELL COUNTER?

ROYCO MODEL 921 CELL COUNTER is a medical device that received FDA 510(k) clearance on 1979-11-05. The listed applicant is Royco Instruments. The 510(k) number is K791867.

When did ROYCO MODEL 921 CELL COUNTER receive FDA 510(k) clearance?

ROYCO MODEL 921 CELL COUNTER received FDA 510(k) clearance on 1979-11-05, under 510(k) number K791867.

Who is the listed applicant for ROYCO MODEL 921 CELL COUNTER?

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

What is the FDA product code for ROYCO MODEL 921 CELL COUNTER?

The FDA product code for ROYCO MODEL 921 CELL COUNTER is GKL.

Related Clinical Trials

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.

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Other records listing Royco Instruments 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.

K800104ROYCO MODEL 951 CELL MIXERK791644ROYCO MODEL 371 SUPER DILUTORK790442ISOTONIC DILUENT

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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