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FDA 510(k)

ACA THYROXINE (T4 E) METHOD

K-Number: K885258 · 1989-02-17

ApplicantThe DU Pont Co.
Decision Date1989-02-17
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACA THYROXINE (T4 E) METHOD 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 1989-02-17 under 510(k) number K885258. 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 ACA THYROXINE (T4 E) METHOD?

ACA THYROXINE (T4 E) METHOD is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is The DU Pont Co.. The 510(k) number is K885258.

When did ACA THYROXINE (T4 E) METHOD receive FDA 510(k) clearance?

ACA THYROXINE (T4 E) METHOD received FDA 510(k) clearance on 1989-02-17, under 510(k) number K885258.

Who is the listed applicant for ACA THYROXINE (T4 E) METHOD?

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 ACA THYROXINE (T4 E) METHOD?

The FDA product code for ACA THYROXINE (T4 E) METHOD 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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