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FDA 510(k)

COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN

K-Number: K961824 · 1996-07-23

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1996-07-23
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN 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 1996-07-23 under 510(k) number K961824. The device is classified under product code DCF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN?

COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN is a medical device that received FDA 510(k) clearance on 1996-07-23. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K961824.

When did COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN receive FDA 510(k) clearance?

COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN received FDA 510(k) clearance on 1996-07-23, under 510(k) number K961824.

Who is the listed applicant for COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN?

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 INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN?

The FDA product code for COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN is DCF.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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.

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: DCF)

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.

K153560Optilite Low Level Albumin KitThe Binding Site Group , Ltd.K121045HUMAN ALBUMIN CSF KITThe Binding Site Group , Ltd.K113072TINA-QUANT ALBUMIN GEN.2Roche Diagnostics OperationsK101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATORMedica Corp.K101203TINA-QUANT ALBUMIN GEN 2Roche DiagnosticsK100853COBAS 8000 MODULAR SERIES ANALYZERRoche Diagnostics Corp.

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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