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FDA 510(k)

COBAS-FP TDM CALIBRATION VERIFICATION TEST SET

K-Number: K962165 · 1996-06-26

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1996-06-26
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS-FP TDM CALIBRATION VERIFICATION TEST SET 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 1996-06-26 under 510(k) number K962165. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS-FP TDM CALIBRATION VERIFICATION TEST SET?

COBAS-FP TDM CALIBRATION VERIFICATION TEST SET is a medical device that received FDA 510(k) clearance on 1996-06-26. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K962165.

When did COBAS-FP TDM CALIBRATION VERIFICATION TEST SET receive FDA 510(k) clearance?

COBAS-FP TDM CALIBRATION VERIFICATION TEST SET received FDA 510(k) clearance on 1996-06-26, under 510(k) number K962165.

Who is the listed applicant for COBAS-FP TDM CALIBRATION VERIFICATION TEST SET?

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-FP TDM CALIBRATION VERIFICATION TEST SET?

The FDA product code for COBAS-FP TDM CALIBRATION VERIFICATION TEST SET is DIF.

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Related Devices (Code: DIF)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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