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FDA 510(k)

SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS

K-Number: K000600 · 2000-03-27

ApplicantSyva Co., Dade Behring, Inc.
Decision Date2000-03-27
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co., Dade Behring, Inc.. It received FDA 510(k) clearance on 2000-03-27 under 510(k) number K000600. 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 SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS?

SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS is a medical device that received FDA 510(k) clearance on 2000-03-27. The listed applicant is Syva Co., Dade Behring, Inc.. The 510(k) number is K000600.

When did SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS receive FDA 510(k) clearance?

SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS received FDA 510(k) clearance on 2000-03-27, under 510(k) number K000600.

Who is the listed applicant for SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS?

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

What is the FDA product code for SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS?

The FDA product code for SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS is KLI.

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Other records listing Syva Co., Dade Behring, 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.

K011920EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229K011620EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229K011605EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229K011300EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229K011306EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229K011161MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229

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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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