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FDA 510(k)

LIPASE REAGENT SET

K-Number: K790796 · 1979-07-17

ApplicantAlta Diagnostics, Inc.
Decision Date1979-07-17
Product CodeCET
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIPASE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Alta Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-07-17 under 510(k) number K790796. 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 SET?

LIPASE REAGENT SET is a medical device that received FDA 510(k) clearance on 1979-07-17. The listed applicant is Alta Diagnostics, Inc.. The 510(k) number is K790796.

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

LIPASE REAGENT SET received FDA 510(k) clearance on 1979-07-17, under 510(k) number K790796.

Who is the listed applicant for LIPASE REAGENT SET?

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

What is the FDA product code for LIPASE REAGENT SET?

The FDA product code for LIPASE REAGENT SET is CET.

Related Clinical Trials

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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Other records listing Alta Diagnostics, 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.

K800327MAGNESIUM REAGENTK792545URIC ACID KITK792546FETAL CHECKK790797AMYLASE REAGENT SET

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 DiagnosticsK940457LIPASE REAGENT SYSTEMMedical Diagnostic Technologies, Inc.K915706LIPASE 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.

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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