FDA 510(k)

TDX C-REACTIVE PROTEIN

K-Number: K854542 · 1986-01-24

Decision Date1986-01-24

Product CodeDCK

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

TDX C-REACTIVE PROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1986-01-24 under 510(k) number K854542. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDX C-REACTIVE PROTEIN?

TDX C-REACTIVE PROTEIN is a medical device that received FDA 510(k) clearance on 1986-01-24. The listed applicant is Abbott Laboratories. The 510(k) number is K854542.

When did TDX C-REACTIVE PROTEIN receive FDA 510(k) clearance?

TDX C-REACTIVE PROTEIN received FDA 510(k) clearance on 1986-01-24, under 510(k) number K854542.

Who is the listed applicant for TDX C-REACTIVE PROTEIN?

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 C-REACTIVE PROTEIN?

The FDA product code for TDX C-REACTIVE PROTEIN is DCK.

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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.