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FDA 510(k)

H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER

K-Number: K883177 · 1988-11-30

ApplicantTexas Intl. Laboratories, Inc.
Decision Date1988-11-30
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER 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 1988-11-30 under 510(k) number K883177. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER?

H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER is a medical device that received FDA 510(k) clearance on 1988-11-30. The listed applicant is Texas Intl. Laboratories, Inc.. The 510(k) number is K883177.

When did H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER receive FDA 510(k) clearance?

H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER received FDA 510(k) clearance on 1988-11-30, under 510(k) number K883177.

Who is the listed applicant for H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER?

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 H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER?

The FDA product code for H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER is GKZ.

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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 12K853722PLT-4 PLATELET ANALYZER

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Related Devices (Code: GKZ)

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex 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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