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FDA 510(k)

COUNTER 700 & HC-700 HEMO 0 REF.

K-Number: K771107 · 1977-07-11

ApplicantHycel, Inc.
Decision Date1977-07-11
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COUNTER 700 & HC-700 HEMO 0 REF. is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1977-07-11 under 510(k) number K771107. 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 COUNTER 700 & HC-700 HEMO 0 REF.?

COUNTER 700 & HC-700 HEMO 0 REF. is a medical device that received FDA 510(k) clearance on 1977-07-11. The listed applicant is Hycel, Inc.. The 510(k) number is K771107.

When did COUNTER 700 & HC-700 HEMO 0 REF. receive FDA 510(k) clearance?

COUNTER 700 & HC-700 HEMO 0 REF. received FDA 510(k) clearance on 1977-07-11, under 510(k) number K771107.

Who is the listed applicant for COUNTER 700 & HC-700 HEMO 0 REF.?

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 COUNTER 700 & HC-700 HEMO 0 REF.?

The FDA product code for COUNTER 700 & HC-700 HEMO 0 REF. 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 TESTK782100HYCEL COUNTER 333K782102HYCEL COUNTER 211

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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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