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FDA 510(k)

ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI

K-Number: K926441 · 1993-05-26

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1993-05-26
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI 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 1993-05-26 under 510(k) number K926441. The device is classified under product code KLT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI?

ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI is a medical device that received FDA 510(k) clearance on 1993-05-26. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K926441.

When did ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI receive FDA 510(k) clearance?

ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI received FDA 510(k) clearance on 1993-05-26, under 510(k) number K926441.

Who is the listed applicant for ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI?

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 ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI?

The FDA product code for ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI is KLT.

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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: KLT)

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.

K123518ABBOTT CARBAMAZEPINE ASSAYMicrogenics CorporationK103627ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORSAbbott LaboratoriesK063131CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLSThermo Electron OYK042808ADVIA IMS CARBAMAZEPINE METHODBayer Healthcare, LLCK031902ONLINE TDM CARBAMAZEPINERoche Diagnostics Corp.K011648RANDOX CARBAMAZEPINERandox Laboratories, Ltd.

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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