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FDA 510(k)

DIGICELL 300 SYSTEM

K-Number: K873271 · 1987-11-06

ApplicantContraves Medical Instruments, Inc.
Decision Date1987-11-06
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIGICELL 300 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Contraves Medical Instruments, Inc.. It received FDA 510(k) clearance on 1987-11-06 under 510(k) number K873271. 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 DIGICELL 300 SYSTEM?

DIGICELL 300 SYSTEM is a medical device that received FDA 510(k) clearance on 1987-11-06. The listed applicant is Contraves Medical Instruments, Inc.. The 510(k) number is K873271.

When did DIGICELL 300 SYSTEM receive FDA 510(k) clearance?

DIGICELL 300 SYSTEM received FDA 510(k) clearance on 1987-11-06, under 510(k) number K873271.

Who is the listed applicant for DIGICELL 300 SYSTEM?

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

What is the FDA product code for DIGICELL 300 SYSTEM?

The FDA product code for DIGICELL 300 SYSTEM 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 Contraves Medical Instruments, 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.

K875346AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)K873252DIGICELL 500

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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