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FDA 510(k)

BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS

K-Number: K875248 · 1988-02-24

ApplicantBioscan Instruments, Inc.
Decision Date1988-02-24
Product CodeJMT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Bioscan Instruments, Inc.. It received FDA 510(k) clearance on 1988-02-24 under 510(k) number K875248. 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 BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS?

BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1988-02-24. The listed applicant is Bioscan Instruments, Inc.. The 510(k) number is K875248.

When did BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS receive FDA 510(k) clearance?

BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS received FDA 510(k) clearance on 1988-02-24, under 510(k) number K875248.

Who is the listed applicant for BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS?

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

What is the FDA product code for BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS?

The FDA product code for BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS is JMT.

Related Clinical Trials

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.

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Other records listing Bioscan Instruments, Inc. as applicant

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.

K940043BIOSCAN REAGENT STRIPS

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

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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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