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FDA 510(k)

MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229

K-Number: K011166 · 2001-05-10

ApplicantSyva Co., Dade Behring, Inc.
Decision Date2001-05-10
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 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 2001-05-10 under 510(k) number K011166. The device is classified under product code KLS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229?

MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 is a medical device that received FDA 510(k) clearance on 2001-05-10. The listed applicant is Syva Co., Dade Behring, Inc.. The 510(k) number is K011166.

When did MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 receive FDA 510(k) clearance?

MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 received FDA 510(k) clearance on 2001-05-10, under 510(k) number K011166.

Who is the listed applicant for MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229?

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 MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229?

The FDA product code for MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 is KLS.

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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: KLS)

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.

K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K042407EMIT CAFFEINE ASSAYDade Behring, Inc.K020740ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.K993029ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89Syva Co.

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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