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FDA 510(k)

COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS

K-Number: K871484 · 1987-05-28

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1987-05-28
Product CodeLGS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS 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 1987-05-28 under 510(k) number K871484. 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 FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS?

COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS is a medical device that received FDA 510(k) clearance on 1987-05-28. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K871484.

When did COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS receive FDA 510(k) clearance?

COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS received FDA 510(k) clearance on 1987-05-28, under 510(k) number K871484.

Who is the listed applicant for COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS?

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 FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS?

The FDA product code for COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS 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.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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