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FDA 510(k)

DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE

K-Number: K990873 · 1999-09-01

ApplicantAmeritek, Inc.
Decision Date1999-09-01
Product CodeJMT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE is the device name listed in this FDA 510(k) record. The listed applicant is Ameritek, Inc.. It received FDA 510(k) clearance on 1999-09-01 under 510(k) number K990873. The device is classified under product code JMT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE?

DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE is a medical device that received FDA 510(k) clearance on 1999-09-01. The listed applicant is Ameritek, Inc.. The 510(k) number is K990873.

When did DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE receive FDA 510(k) clearance?

DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE received FDA 510(k) clearance on 1999-09-01, under 510(k) number K990873.

Who is the listed applicant for DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE?

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

What is the FDA product code for DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE?

The FDA product code for DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE is JMT.

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Other records listing Ameritek, Inc. as applicant

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K001215DBEST HCG 2 IU/ML TEST KITK990681DBSET MULTIDRUG SCREEN TEST KITK984269DBEST OCCULT BLOOD TEST KITK983188DBEST TETRAHYDROCANNABINOL TEST KITK983191DBEST COCAINE TEST KITK983190DBEST OPIATES TEST KIT

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Related Devices (Code: JMT)

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.

K251800Healgen® URS Test StripsHealgen Scientific,, LLCK252607AllTest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.K242767Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd.K170118Scanostics UTI Check Application Test SystemTeco DiagnosticsK100024TECO DIAGNOSTICS UTI DETECTION STRIPSTeco DiagnosticsK993850URINALYSIS REAGENT STRIPS (10 PARAMETERS)International Newtech Development, 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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