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FDA 510(k)

REAGENT, AMYLASE LIPASE

K-Number: K770400 · 1977-04-26

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1977-04-26
Product CodeKHM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT, AMYLASE LIPASE is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1977-04-26 under 510(k) number K770400. 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 REAGENT, AMYLASE LIPASE?

REAGENT, AMYLASE LIPASE is a medical device that received FDA 510(k) clearance on 1977-04-26. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K770400.

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

REAGENT, AMYLASE LIPASE received FDA 510(k) clearance on 1977-04-26, under 510(k) number K770400.

Who is the listed applicant for REAGENT, AMYLASE LIPASE?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REAGENT, AMYLASE LIPASE?

The FDA product code for REAGENT, AMYLASE LIPASE is KHM.

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Related Devices (Code: KHM)

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K831295AMYLASE REAGENT #88129Hi Chem, Inc.K812699AMYLASEPointe Scientific, Inc.,K812447AMYLASE REAGENT KITBioscientificK801096PERKIN ELMER MODEL 91 AMYLASE REAGENTStat EngineeringK790797AMYLASE REAGENT SETAlta 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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