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FDA 510(k)

VITRO T4-EIA-XT

K-Number: K896865 · 1990-01-30

ApplicantIn Vitro Diagnostics, Inc.
Decision Date1990-01-30
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITRO T4-EIA-XT is the device name listed in this FDA 510(k) record. The listed applicant is In Vitro Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-01-30 under 510(k) number K896865. 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 VITRO T4-EIA-XT?

VITRO T4-EIA-XT is a medical device that received FDA 510(k) clearance on 1990-01-30. The listed applicant is In Vitro Diagnostics, Inc.. The 510(k) number is K896865.

When did VITRO T4-EIA-XT receive FDA 510(k) clearance?

VITRO T4-EIA-XT received FDA 510(k) clearance on 1990-01-30, under 510(k) number K896865.

Who is the listed applicant for VITRO T4-EIA-XT?

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

What is the FDA product code for VITRO T4-EIA-XT?

The FDA product code for VITRO T4-EIA-XT is KLI.

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Other records listing In Vitro Diagnostics, 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.

K896867THYROID STIMULATING HORMONE-EIA-XTK896863DIGOXIN-EIA-XTK896866LUTEINIZING HORMONE-EIA-XTK896925T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KITK896864FOLLICLE STIMULATING HORMONE-EIA-XTK873832REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801

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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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