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FDA 510(k)

PERKIN ELMER MODEL 91 AMYLASE REAGENT

K-Number: K801096 · 1980-06-09

ApplicantStat Engineering
Decision Date1980-06-09
Product CodeKHM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PERKIN ELMER MODEL 91 AMYLASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Stat Engineering. It received FDA 510(k) clearance on 1980-06-09 under 510(k) number K801096. 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 PERKIN ELMER MODEL 91 AMYLASE REAGENT?

PERKIN ELMER MODEL 91 AMYLASE REAGENT is a medical device that received FDA 510(k) clearance on 1980-06-09. The listed applicant is Stat Engineering. The 510(k) number is K801096.

When did PERKIN ELMER MODEL 91 AMYLASE REAGENT receive FDA 510(k) clearance?

PERKIN ELMER MODEL 91 AMYLASE REAGENT received FDA 510(k) clearance on 1980-06-09, under 510(k) number K801096.

Who is the listed applicant for PERKIN ELMER MODEL 91 AMYLASE REAGENT?

The FDA 510(k) record lists Stat Engineering as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERKIN ELMER MODEL 91 AMYLASE REAGENT?

The FDA product code for PERKIN ELMER MODEL 91 AMYLASE REAGENT is KHM.

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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 KITBioscientificK790797AMYLASE REAGENT SETAlta Diagnostics, Inc.K770400REAGENT, 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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