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FDA 510(k)

COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS

K-Number: K926443 · 1993-05-20

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1993-05-20
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS(R)-FP REAGENTS FOR T-UPTAKE/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 1993-05-20 under 510(k) number K926443. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS?

COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS is a medical device that received FDA 510(k) clearance on 1993-05-20. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K926443.

When did COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS receive FDA 510(k) clearance?

COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS received FDA 510(k) clearance on 1993-05-20, under 510(k) number K926443.

Who is the listed applicant for COBAS(R)-FP REAGENTS FOR T-UPTAKE/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(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS?

The FDA product code for COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS is KHQ.

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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: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim 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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