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FDA 510(k)

CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER

K-Number: K900685 · 1990-04-16

ApplicantTexas Intl. Laboratories, Inc.
Decision Date1990-04-16
Product CodeKQG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CLOT 2 SEMIAUTOMATIC COAGULATION 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 1990-04-16 under 510(k) number K900685. The device is classified under product code KQG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER?

CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is Texas Intl. Laboratories, Inc.. The 510(k) number is K900685.

When did CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER receive FDA 510(k) clearance?

CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER received FDA 510(k) clearance on 1990-04-16, under 510(k) number K900685.

Who is the listed applicant for CLOT 2 SEMIAUTOMATIC COAGULATION 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 CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER?

The FDA product code for CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER is KQG.

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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 SYSTEMK900684RDW 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: KQG)

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.

K050821COAGCARE ANTICOAGULATION MANAGEMENT SYSTEMZycareK021976FIBRON-1, FIBRON-4, QUIKCOAG, FIBRONVital Scientific N.V.K992130PACIFIC HEMOSTASIS THROMBOSCREEN 400CPacific HemostasisK991321PACIFIC HEMOSTASIS THROMBOSCREEN 200Pacific HemostasisK983475HEMOCHRON RESPONSEInternational Technidyne Corp.K902614ELVI 828 DIGICLOT MULTISCANLogos Scientific, 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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