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FDA 510(k)

DIA SCREEN 10 WAY REAGENT STRIPS

K-Number: K961375 · 1996-06-18

ApplicantGenesis Labs, Inc.
Decision Date1996-06-18
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIA SCREEN 10 WAY REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Labs, Inc.. It received FDA 510(k) clearance on 1996-06-18 under 510(k) number K961375. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIA SCREEN 10 WAY REAGENT STRIPS?

DIA SCREEN 10 WAY REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1996-06-18. The listed applicant is Genesis Labs, Inc.. The 510(k) number is K961375.

When did DIA SCREEN 10 WAY REAGENT STRIPS receive FDA 510(k) clearance?

DIA SCREEN 10 WAY REAGENT STRIPS received FDA 510(k) clearance on 1996-06-18, under 510(k) number K961375.

Who is the listed applicant for DIA SCREEN 10 WAY REAGENT STRIPS?

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

What is the FDA product code for DIA SCREEN 10 WAY REAGENT STRIPS?

The FDA product code for DIA SCREEN 10 WAY REAGENT STRIPS is JIL.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Genesis Labs, 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.

K952971DIA SCREEN REAGENT STRIPSK943008BIOSCAN REAGENT STRIPS

Related Devices (Code: JIL)

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.

K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.K183432cobas u 601 urinalysis test systemRoche DiagnosticsK173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd.K180356inui In-Home Urine Analysis Test SystemScanadu, Inc.K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd.K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd.

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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