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FDA 510(k)

AMYLASE REAGENT SET

K-Number: K790797 · 1979-07-17

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

Device Summary

AMYLASE 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 K790797. The device is classified under product code KHM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMYLASE REAGENT SET?

AMYLASE 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 K790797.

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

AMYLASE REAGENT SET received FDA 510(k) clearance on 1979-07-17, under 510(k) number K790797.

Who is the listed applicant for AMYLASE 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 AMYLASE REAGENT SET?

The FDA product code for AMYLASE REAGENT SET is KHM.

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 CHECKK790796LIPASE REAGENT SET

Related Devices (Code: KHM)

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.

K831295AMYLASE REAGENT #88129Hi Chem, Inc.K812699AMYLASEPointe Scientific, Inc.,K812447AMYLASE REAGENT KITBioscientificK801096PERKIN ELMER MODEL 91 AMYLASE REAGENTStat EngineeringK770400REAGENT, AMYLASE LIPASEBd Becton Dickinson Vacutainer Systems Preanalytic

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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