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FDA 510(k)

URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)

K-Number: K954977 · 1996-03-11

ApplicantTeco Diagnostics
Decision Date1996-03-11
Product CodeJRE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 1996-03-11 under 510(k) number K954977. The device is classified under product code JRE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)?

URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-03-11. The listed applicant is Teco Diagnostics. The 510(k) number is K954977.

When did URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) receive FDA 510(k) clearance?

URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) received FDA 510(k) clearance on 1996-03-11, under 510(k) number K954977.

Who is the listed applicant for URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)?

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 URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)?

The FDA product code for URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) is JRE.

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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: JRE)

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.

K941906MODEL 2730 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941903MODEL 2740 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941901MODEL 2721 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941905MODEL 3461 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941904MODEL A300CL CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941902MODEL 3471 CLINICAL REFRACTOMETERVee Gee Scientific, 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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