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FDA 510(k)

URINALYSIS REAGENT STRIPS (10 PARAMETERS)

K-Number: K993850 · 2000-01-03

ApplicantInternational Newtech Development, Inc.
Decision Date2000-01-03
Product CodeJMT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINALYSIS REAGENT STRIPS (10 PARAMETERS) is the device name listed in this FDA 510(k) record. The listed applicant is International Newtech Development, Inc.. It received FDA 510(k) clearance on 2000-01-03 under 510(k) number K993850. 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 URINALYSIS REAGENT STRIPS (10 PARAMETERS)?

URINALYSIS REAGENT STRIPS (10 PARAMETERS) is a medical device that received FDA 510(k) clearance on 2000-01-03. The listed applicant is International Newtech Development, Inc.. The 510(k) number is K993850.

When did URINALYSIS REAGENT STRIPS (10 PARAMETERS) receive FDA 510(k) clearance?

URINALYSIS REAGENT STRIPS (10 PARAMETERS) received FDA 510(k) clearance on 2000-01-03, under 510(k) number K993850.

Who is the listed applicant for URINALYSIS REAGENT STRIPS (10 PARAMETERS)?

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

What is the FDA product code for URINALYSIS REAGENT STRIPS (10 PARAMETERS)?

The FDA product code for URINALYSIS REAGENT STRIPS (10 PARAMETERS) is JMT.

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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 DiagnosticsK990873DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USEAmeritek, 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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