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FDA 510(k)

LIPASE UV [TOYO]

K-Number: K874027 · 1988-05-27

ApplicantAdvocacy International, Ltd.
Decision Date1988-05-27
Product CodeCHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIPASE UV [TOYO] is the device name listed in this FDA 510(k) record. The listed applicant is Advocacy International, Ltd.. It received FDA 510(k) clearance on 1988-05-27 under 510(k) number K874027. The device is classified under product code CHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIPASE UV [TOYO]?

LIPASE UV [TOYO] is a medical device that received FDA 510(k) clearance on 1988-05-27. The listed applicant is Advocacy International, Ltd.. The 510(k) number is K874027.

When did LIPASE UV [TOYO] receive FDA 510(k) clearance?

LIPASE UV [TOYO] received FDA 510(k) clearance on 1988-05-27, under 510(k) number K874027.

Who is the listed applicant for LIPASE UV [TOYO]?

The FDA 510(k) record lists Advocacy International, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIPASE UV [TOYO]?

The FDA product code for LIPASE UV [TOYO] is CHI.

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Other records listing Advocacy International, Ltd. 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.

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Related Devices (Code: CHI)

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.

K970905SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENTBeckman Instruments, Inc.K961179SENTINEL LIPASE LIQUID MODEL 17.401BEqual Diagnostics, Inc.K952180CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMSBeckman Instruments, Inc.K952647IL TEST LIPASEInstrumentation Laboratory COK952816LIPASE FLEX REAGENT CARTRIDGEDupont Medical ProductsK941085LIPASE-PS ASSAY PROCEDURE NO. 805Sigma Diagnostics, 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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