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FDA 510(k)

ONLINE DAT PHENCYCLIDINE PLUS

K-Number: K043305 · 2005-01-10

ApplicantRoche Diagnostics Corp.
Decision Date2005-01-10
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

ONLINE DAT PHENCYCLIDINE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2005-01-10 under 510(k) number K043305. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONLINE DAT PHENCYCLIDINE PLUS?

ONLINE DAT PHENCYCLIDINE PLUS is a medical device that received FDA 510(k) clearance on 2005-01-10. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K043305.

When did ONLINE DAT PHENCYCLIDINE PLUS receive FDA 510(k) clearance?

ONLINE DAT PHENCYCLIDINE PLUS received FDA 510(k) clearance on 2005-01-10, under 510(k) number K043305.

Who is the listed applicant for ONLINE DAT PHENCYCLIDINE PLUS?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONLINE DAT PHENCYCLIDINE PLUS?

The FDA product code for ONLINE DAT PHENCYCLIDINE PLUS is LCM.

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Other records listing Roche Diagnostics Corp. as applicant

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Related Devices (Code: LCM)

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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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