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FDA 510(k)

URINE REAGENT STRIPS-8 PARAMETERS

K-Number: K943436 · 1995-04-24

ApplicantTeco Diagnostics
Decision Date1995-04-24
Product CodeJJB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINE REAGENT STRIPS-8 PARAMETERS is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 1995-04-24 under 510(k) number K943436. The device is classified under product code JJB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE REAGENT STRIPS-8 PARAMETERS?

URINE REAGENT STRIPS-8 PARAMETERS is a medical device that received FDA 510(k) clearance on 1995-04-24. The listed applicant is Teco Diagnostics. The 510(k) number is K943436.

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

URINE REAGENT STRIPS-8 PARAMETERS received FDA 510(k) clearance on 1995-04-24, under 510(k) number K943436.

Who is the listed applicant for URINE REAGENT STRIPS-8 PARAMETERS?

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 REAGENT STRIPS-8 PARAMETERS?

The FDA product code for URINE REAGENT STRIPS-8 PARAMETERS is JJB.

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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: JJB)

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.

K943008BIOSCAN REAGENT STRIPSGenesis Labs, Inc.K873553WAKO(TM) PRETEST 8AWako Chemicals USA, Inc.K862806URINE DIAGNOSTIC REAGENT STRIPSAmatech International, Inc.K833521REAGENT TESTS STRIP COMBINATIONSSyn-Kit, 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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