Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET

K-Number: K942648 · 1995-03-24

ApplicantTeco Diagnostics
Decision Date1995-03-24
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 1995-03-24 under 510(k) number K942648. 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 IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET?

IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET is a medical device that received FDA 510(k) clearance on 1995-03-24. The listed applicant is Teco Diagnostics. The 510(k) number is K942648.

When did IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET receive FDA 510(k) clearance?

IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET received FDA 510(k) clearance on 1995-03-24, under 510(k) number K942648.

Who is the listed applicant for IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET?

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

What is the FDA product code for IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET?

The FDA product code for IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET 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 Teco Diagnostics 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.

K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERK072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440

View all 49 devices →

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.

↑