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FDA 510(k)

RA LATEX TEST

K-Number: K812972 · 1981-11-06

Decision Date1981-11-06
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RA LATEX TEST is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid U.S.A., Inc.. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812972. 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 RA LATEX TEST?

RA LATEX TEST is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K812972.

When did RA LATEX TEST receive FDA 510(k) clearance?

RA LATEX TEST received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812972.

Who is the listed applicant for RA LATEX TEST?

The FDA 510(k) record lists Oxoid U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RA LATEX TEST?

The FDA product code for RA LATEX TEST is DHR.

Related Clinical Trials

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.

Other records listing Oxoid U.S.A., Inc. as applicant

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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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.

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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