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FDA 510(k)

HYCEL COUNTER 211

K-Number: K782102 · 1979-01-03

ApplicantHycel, Inc.
Decision Date1979-01-03
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HYCEL COUNTER 211 is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1979-01-03 under 510(k) number K782102. 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 HYCEL COUNTER 211?

HYCEL COUNTER 211 is a medical device that received FDA 510(k) clearance on 1979-01-03. The listed applicant is Hycel, Inc.. The 510(k) number is K782102.

When did HYCEL COUNTER 211 receive FDA 510(k) clearance?

HYCEL COUNTER 211 received FDA 510(k) clearance on 1979-01-03, under 510(k) number K782102.

Who is the listed applicant for HYCEL COUNTER 211?

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

What is the FDA product code for HYCEL COUNTER 211?

The FDA product code for HYCEL COUNTER 211 is GKL.

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Other records listing Hycel, 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.

K802422HYCEL TRIGYCERIDE II TESTK790335HYCEL MK782116KETOSTEROID TEST, HYCEL-17K782176HYCEL LDH-INT TESTK782101HYCEL COUNTER 222K782100HYCEL COUNTER 333

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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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