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FDA 510(k)

VISTA THYROXINE (T-4) ASSAY -- MODIFICATION

K-Number: K922433 · 1992-09-18

ApplicantSyva Co.
Decision Date1992-09-18
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VISTA THYROXINE (T-4) ASSAY -- MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1992-09-18 under 510(k) number K922433. 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 VISTA THYROXINE (T-4) ASSAY -- MODIFICATION?

VISTA THYROXINE (T-4) ASSAY -- MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-09-18. The listed applicant is Syva Co.. The 510(k) number is K922433.

When did VISTA THYROXINE (T-4) ASSAY -- MODIFICATION receive FDA 510(k) clearance?

VISTA THYROXINE (T-4) ASSAY -- MODIFICATION received FDA 510(k) clearance on 1992-09-18, under 510(k) number K922433.

Who is the listed applicant for VISTA THYROXINE (T-4) ASSAY -- MODIFICATION?

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

What is the FDA product code for VISTA THYROXINE (T-4) ASSAY -- MODIFICATION?

The FDA product code for VISTA THYROXINE (T-4) ASSAY -- MODIFICATION is KLI.

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Other records listing Syva Co. as applicant

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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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