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FDA 510(k)

VENTREZYME T4 IMMUNOASSAY T4

K-Number: K840473 · 1984-04-04

ApplicantVxr, Inc.
Decision Date1984-04-04
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VENTREZYME T4 IMMUNOASSAY T4 is the device name listed in this FDA 510(k) record. The listed applicant is Vxr, Inc.. It received FDA 510(k) clearance on 1984-04-04 under 510(k) number K840473. 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 VENTREZYME T4 IMMUNOASSAY T4?

VENTREZYME T4 IMMUNOASSAY T4 is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is Vxr, Inc.. The 510(k) number is K840473.

When did VENTREZYME T4 IMMUNOASSAY T4 receive FDA 510(k) clearance?

VENTREZYME T4 IMMUNOASSAY T4 received FDA 510(k) clearance on 1984-04-04, under 510(k) number K840473.

Who is the listed applicant for VENTREZYME T4 IMMUNOASSAY T4?

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

What is the FDA product code for VENTREZYME T4 IMMUNOASSAY T4?

The FDA product code for VENTREZYME T4 IMMUNOASSAY T4 is KLI.

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Other records listing Vxr, Inc. 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.

K853703VENTREZYME T3 IMMUNOASSAY T3K853748VENTRESCREEN HCG URINEK841456VENTREXYME EIA CONTROLS IMMUNOASSAYK833960VENTREX PREGNANCY TEST KIT ENZYMEK833989VENTREZYME THEOPHYLLINE IMMUNOASSAYK833878VENTREZYME DIGOXIN IMMUNOASSAY DIGOX

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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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