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FDA 510(k)

HEMATIL 18 (H-18)

K-Number: K953643 · 1996-03-22

ApplicantTexas Intl. Laboratories, Inc.
Decision Date1996-03-22
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATIL 18 (H-18) 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 1996-03-22 under 510(k) number K953643. 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 HEMATIL 18 (H-18)?

HEMATIL 18 (H-18) is a medical device that received FDA 510(k) clearance on 1996-03-22. The listed applicant is Texas Intl. Laboratories, Inc.. The 510(k) number is K953643.

When did HEMATIL 18 (H-18) receive FDA 510(k) clearance?

HEMATIL 18 (H-18) received FDA 510(k) clearance on 1996-03-22, under 510(k) number K953643.

Who is the listed applicant for HEMATIL 18 (H-18)?

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 HEMATIL 18 (H-18)?

The FDA product code for HEMATIL 18 (H-18) 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.

K904031CHEMA CHOL CHOLESTEROL SYSTEMK900685CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZERK900684RDW AND MPV INDICES ON HEMAT 12K884006HEMAT 12K883177H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTERK853722PLT-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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