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FDA 510(k)

MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR

K-Number: K871680 · 1987-06-08

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1987-06-08
Product CodeLAN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR 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 1987-06-08 under 510(k) number K871680. The device is classified under product code LAN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR?

MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR is a medical device that received FDA 510(k) clearance on 1987-06-08. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K871680.

When did MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR receive FDA 510(k) clearance?

MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR received FDA 510(k) clearance on 1987-06-08, under 510(k) number K871680.

Who is the listed applicant for MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR?

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 MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR?

The FDA product code for MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR is LAN.

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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: LAN)

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.

K060738TDM N-ACETYLPROCAINAMIDERoche Diagnostics Corp.K032564DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111Dade Behring, Inc.K011620EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229Syva Co., Dade Behring, Inc.K983812NAPA EIA ASSAYDiagnostic Reagents, Inc.K971713N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.K955422AXSYM N-ACETYLPROCAINAMIDEAbbott 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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