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FDA 510(k)

ANALYST THYROXINE (T4) ROTOR

K-Number: K884700 · 1989-01-27

ApplicantThe DU Pont Co.
Decision Date1989-01-27
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANALYST THYROXINE (T4) ROTOR is the device name listed in this FDA 510(k) record. The listed applicant is The DU Pont Co.. It received FDA 510(k) clearance on 1989-01-27 under 510(k) number K884700. 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 ANALYST THYROXINE (T4) ROTOR?

ANALYST THYROXINE (T4) ROTOR is a medical device that received FDA 510(k) clearance on 1989-01-27. The listed applicant is The DU Pont Co.. The 510(k) number is K884700.

When did ANALYST THYROXINE (T4) ROTOR receive FDA 510(k) clearance?

ANALYST THYROXINE (T4) ROTOR received FDA 510(k) clearance on 1989-01-27, under 510(k) number K884700.

Who is the listed applicant for ANALYST THYROXINE (T4) ROTOR?

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

What is the FDA product code for ANALYST THYROXINE (T4) ROTOR?

The FDA product code for ANALYST THYROXINE (T4) ROTOR is KLI.

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Other records listing The DU Pont Co. 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.

K953475CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGINGK953477MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGINGK952891CRONEX LOW ABSORPTION CASSETTEK945125DUPONT ACA VANCOMYCIN (VANC) METHODK943704LIPASE CALIBRATORK900492LABELING CHANGE - VIASPAN(TM) (BELZER UW)

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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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