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FDA 510(k)

TEST FOR KETONE IN URINE(ACETOACETIC AC

K-Number: K801270 · 1980-07-08

ApplicantMiles Laboratories, Inc.
Decision Date1980-07-08
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TEST FOR KETONE IN URINE(ACETOACETIC AC is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801270. The device is classified under product code JIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEST FOR KETONE IN URINE(ACETOACETIC AC?

TEST FOR KETONE IN URINE(ACETOACETIC AC is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K801270.

When did TEST FOR KETONE IN URINE(ACETOACETIC AC receive FDA 510(k) clearance?

TEST FOR KETONE IN URINE(ACETOACETIC AC received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801270.

Who is the listed applicant for TEST FOR KETONE IN URINE(ACETOACETIC AC?

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

What is the FDA product code for TEST FOR KETONE IN URINE(ACETOACETIC AC?

The FDA product code for TEST FOR KETONE IN URINE(ACETOACETIC AC is JIN.

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Related Devices (Code: JIN)

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.

K201551KetoSens BT Blood B-Ketone Monitoring SystemI-Sens, Inc.K192957VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.K182593KET-1 Blood Ketone Monitoring SystemApex BioTechnology Corp.K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology CorporationK170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc.K170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for UrinalysisACON Laboratories, 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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