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FDA 510(k)

AXSYM THEOPHYLLINE II

K-Number: K953016 · 1995-08-24

ApplicantAbbott Laboratories
Decision Date1995-08-24
Product CodeLGS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AXSYM THEOPHYLLINE II is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1995-08-24 under 510(k) number K953016. The device is classified under product code LGS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXSYM THEOPHYLLINE II?

AXSYM THEOPHYLLINE II is a medical device that received FDA 510(k) clearance on 1995-08-24. The listed applicant is Abbott Laboratories. The 510(k) number is K953016.

When did AXSYM THEOPHYLLINE II receive FDA 510(k) clearance?

AXSYM THEOPHYLLINE II received FDA 510(k) clearance on 1995-08-24, under 510(k) number K953016.

Who is the listed applicant for AXSYM THEOPHYLLINE II?

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 AXSYM THEOPHYLLINE II?

The FDA product code for AXSYM THEOPHYLLINE II is LGS.

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Related Devices (Code: LGS)

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.

K070810ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)Biokit, S.A.K955567INNOFLUOR THEOPHYLLINE ASSAY SYSTEMOxis Intl., Inc.K951169CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAYCiba Corning Diagnostics Corp.K942991QMS THEOPHYLLINE CSSeradyn, Inc.K932127TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL IIAbbott LaboratoriesK922991ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINEAbbott Laboratories

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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