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FDA 510(k)

CHEM KIT THEOPHYLLINE DIAG. KIT

K-Number: K833683 · 1983-12-27

ApplicantAbbott Laboratories
Decision Date1983-12-27
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CHEM KIT THEOPHYLLINE DIAG. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1983-12-27 under 510(k) number K833683. 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 CHEM KIT THEOPHYLLINE DIAG. KIT?

CHEM KIT THEOPHYLLINE DIAG. KIT is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is Abbott Laboratories. The 510(k) number is K833683.

When did CHEM KIT THEOPHYLLINE DIAG. KIT receive FDA 510(k) clearance?

CHEM KIT THEOPHYLLINE DIAG. KIT received FDA 510(k) clearance on 1983-12-27, under 510(k) number K833683.

Who is the listed applicant for CHEM KIT THEOPHYLLINE DIAG. KIT?

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 CHEM KIT THEOPHYLLINE DIAG. KIT?

The FDA product code for CHEM KIT THEOPHYLLINE DIAG. KIT is KLS.

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Other records listing Abbott Laboratories as applicant

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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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