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FDA 510(k)

RA-1000 SYS-T4(THYROXINE)SERUM ANAL

K-Number: K834102 · 1984-03-15

ApplicantTechnicon Instruments Corp.
Decision Date1984-03-15
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RA-1000 SYS-T4(THYROXINE)SERUM ANAL 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 1984-03-15 under 510(k) number K834102. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RA-1000 SYS-T4(THYROXINE)SERUM ANAL?

RA-1000 SYS-T4(THYROXINE)SERUM ANAL is a medical device that received FDA 510(k) clearance on 1984-03-15. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K834102.

When did RA-1000 SYS-T4(THYROXINE)SERUM ANAL receive FDA 510(k) clearance?

RA-1000 SYS-T4(THYROXINE)SERUM ANAL received FDA 510(k) clearance on 1984-03-15, under 510(k) number K834102.

Who is the listed applicant for RA-1000 SYS-T4(THYROXINE)SERUM ANAL?

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 RA-1000 SYS-T4(THYROXINE)SERUM ANAL?

The FDA product code for RA-1000 SYS-T4(THYROXINE)SERUM ANAL is KLI.

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Other records listing Technicon Instruments Corp. as applicant

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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: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman Coulter, 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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