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FDA 510(k)

LIPASE REAGENT SYSTEM

K-Number: K940457 · 1994-06-02

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1994-06-02
Product CodeCET
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIPASE REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1994-06-02 under 510(k) number K940457. The device is classified under product code CET. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIPASE REAGENT SYSTEM?

LIPASE REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1994-06-02. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K940457.

When did LIPASE REAGENT SYSTEM receive FDA 510(k) clearance?

LIPASE REAGENT SYSTEM received FDA 510(k) clearance on 1994-06-02, under 510(k) number K940457.

Who is the listed applicant for LIPASE REAGENT SYSTEM?

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

What is the FDA product code for LIPASE REAGENT SYSTEM?

The FDA product code for LIPASE REAGENT SYSTEM is CET.

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Other records listing Medical Diagnostic Technologies, 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.

K062229CTC WORKSTATION, MODEL 2200K972209SPECTROLYSE HEPARIN (ANTI-IIA)K963106CHROMOLIZE PAI-1 KITK960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)K962489CHROMOLIZE TPA ASSAY KITK960438TINTELIZE PAI-1 KIT

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Related Devices (Code: CET)

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.

K970124LIPASE REAGENT SET (COLIPASE METHOD)Teco DiagnosticsK915706LIPASE REAGENT SETTech Intl. Co.K901858MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TESTE.I. Dupont DE Nemours & Co., Inc.K893718DELTATEST (R) LIPASE IIElectro-Nucleonics, Inc.K885078LIPASE SR LIQUID STABLE REAGENT SETMedical Analysis Systems, Inc.K864438BECKMAN EPSILON(TM) LIPASE TEST KITBeckman Instruments, 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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