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FDA 510(k)

COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL

K-Number: K843826 · 1985-02-01

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1985-02-01
Product CodeLGS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1985-02-01 under 510(k) number K843826. 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 COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL?

COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL is a medical device that received FDA 510(k) clearance on 1985-02-01. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K843826.

When did COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL receive FDA 510(k) clearance?

COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL received FDA 510(k) clearance on 1985-02-01, under 510(k) number K843826.

Who is the listed applicant for COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL?

The FDA 510(k) record lists Roche Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL?

The FDA product code for COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL is LGS.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

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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.K953016AXSYM THEOPHYLLINE IIAbbott LaboratoriesK951169CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAYCiba Corning Diagnostics Corp.K942991QMS THEOPHYLLINE CSSeradyn, Inc.K932127TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL IIAbbott 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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