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FDA 510(k)

RHEUMA-CHECK ENZYME IMMUNOASSAY TEST

K-Number: K871196 · 1987-05-06

ApplicantOrion Diagnostica, Inc.
Decision Date1987-05-06
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMA-CHECK ENZYME IMMUNOASSAY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Inc.. It received FDA 510(k) clearance on 1987-05-06 under 510(k) number K871196. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHEUMA-CHECK ENZYME IMMUNOASSAY TEST?

RHEUMA-CHECK ENZYME IMMUNOASSAY TEST is a medical device that received FDA 510(k) clearance on 1987-05-06. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K871196.

When did RHEUMA-CHECK ENZYME IMMUNOASSAY TEST receive FDA 510(k) clearance?

RHEUMA-CHECK ENZYME IMMUNOASSAY TEST received FDA 510(k) clearance on 1987-05-06, under 510(k) number K871196.

Who is the listed applicant for RHEUMA-CHECK ENZYME IMMUNOASSAY TEST?

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

What is the FDA product code for RHEUMA-CHECK ENZYME IMMUNOASSAY TEST?

The FDA product code for RHEUMA-CHECK ENZYME IMMUNOASSAY TEST is DHR.

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Other records listing Orion Diagnostica, Inc. as applicant

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Related Devices (Code: DHR)

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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