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FDA 510(k)

COBAS (R) CORE T4 EIA

K-Number: K932605 · 1994-01-24

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1994-01-24
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS (R) CORE T4 EIA 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 1994-01-24 under 510(k) number K932605. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS (R) CORE T4 EIA?

COBAS (R) CORE T4 EIA is a medical device that received FDA 510(k) clearance on 1994-01-24. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K932605.

When did COBAS (R) CORE T4 EIA receive FDA 510(k) clearance?

COBAS (R) CORE T4 EIA received FDA 510(k) clearance on 1994-01-24, under 510(k) number K932605.

Who is the listed applicant for COBAS (R) CORE T4 EIA?

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) CORE T4 EIA?

The FDA product code for COBAS (R) CORE T4 EIA is KLI.

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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: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman Coulter, Inc.

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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