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FDA 510(k)

VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM

K-Number: K860464 · 1986-06-17

ApplicantAbbott Laboratories
Decision Date1986-06-17
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1986-06-17 under 510(k) number K860464. 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 VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM?

VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM is a medical device that received FDA 510(k) clearance on 1986-06-17. The listed applicant is Abbott Laboratories. The 510(k) number is K860464.

When did VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM receive FDA 510(k) clearance?

VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM received FDA 510(k) clearance on 1986-06-17, under 510(k) number K860464.

Who is the listed applicant for VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM?

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

What is the FDA product code for VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM?

The FDA product code for VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM is KLS.

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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.K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., Dade Behring, 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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