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FDA 510(k)

IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN

K-Number: K860679 · 1986-08-04

ApplicantOrion Corp.
Decision Date1986-08-04
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent for Some Indications

Device Summary

IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corp.. It received FDA 510(k) clearance on 1986-08-04 under 510(k) number K860679. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN?

IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN is a medical device that received FDA 510(k) clearance on 1986-08-04. The listed applicant is Orion Corp.. The 510(k) number is K860679.

When did IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN receive FDA 510(k) clearance?

IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN received FDA 510(k) clearance on 1986-08-04, under 510(k) number K860679.

Who is the listed applicant for IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN?

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

What is the FDA product code for IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN?

The FDA product code for IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN is DCN.

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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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