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FDA 510(k)

PLT-4 PLATELET ANALYZER

K-Number: K853722 · 1986-01-17

ApplicantTexas Intl. Laboratories, Inc.
Decision Date1986-01-17
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLT-4 PLATELET ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Texas Intl. Laboratories, Inc.. It received FDA 510(k) clearance on 1986-01-17 under 510(k) number K853722. 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 PLT-4 PLATELET ANALYZER?

PLT-4 PLATELET ANALYZER is a medical device that received FDA 510(k) clearance on 1986-01-17. The listed applicant is Texas Intl. Laboratories, Inc.. The 510(k) number is K853722.

When did PLT-4 PLATELET ANALYZER receive FDA 510(k) clearance?

PLT-4 PLATELET ANALYZER received FDA 510(k) clearance on 1986-01-17, under 510(k) number K853722.

Who is the listed applicant for PLT-4 PLATELET ANALYZER?

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

What is the FDA product code for PLT-4 PLATELET ANALYZER?

The FDA product code for PLT-4 PLATELET ANALYZER is GKL.

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Other records listing Texas Intl. Laboratories, 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.

K953643HEMATIL 18 (H-18)K904031CHEMA CHOL CHOLESTEROL SYSTEMK900685CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZERK900684RDW AND MPV INDICES ON HEMAT 12K884006HEMAT 12K883177H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER

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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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