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FDA 510(k)

TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES

K-Number: K902243 · 1990-07-05

ApplicantTechnicon Instruments Corp.
Decision Date1990-07-05
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1990-07-05 under 510(k) number K902243. The device is classified under product code KLS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES?

TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES is a medical device that received FDA 510(k) clearance on 1990-07-05. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K902243.

When did TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES receive FDA 510(k) clearance?

TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES received FDA 510(k) clearance on 1990-07-05, under 510(k) number K902243.

Who is the listed applicant for TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES?

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

What is the FDA product code for TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES?

The FDA product code for TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES is KLS.

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Other records listing Technicon Instruments Corp. 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.

K914888TECHNICON CHEM 1(TM) SYST (GEN2 SYST)K914511TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOLK914025TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)K912616TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTESK912413CHEM-LINK DATA BASE MANAGERK903824DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY

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Related Devices (Code: KLS)

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.

K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K042407EMIT CAFFEINE ASSAYDade Behring, Inc.K020740ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., Dade Behring, 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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