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FDA 510(k)

TDX PHENCYCLIDINE II ASSAY

K-Number: K900940 · 1990-04-25

ApplicantAbbott Laboratories
Decision Date1990-04-25
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

TDX PHENCYCLIDINE II ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1990-04-25 under 510(k) number K900940. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDX PHENCYCLIDINE II ASSAY?

TDX PHENCYCLIDINE II ASSAY is a medical device that received FDA 510(k) clearance on 1990-04-25. The listed applicant is Abbott Laboratories. The 510(k) number is K900940.

When did TDX PHENCYCLIDINE II ASSAY receive FDA 510(k) clearance?

TDX PHENCYCLIDINE II ASSAY received FDA 510(k) clearance on 1990-04-25, under 510(k) number K900940.

Who is the listed applicant for TDX PHENCYCLIDINE II ASSAY?

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

What is the FDA product code for TDX PHENCYCLIDINE II ASSAY?

The FDA product code for TDX PHENCYCLIDINE II ASSAY is LCM.

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Related Devices (Code: LCM)

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.

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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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