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FDA 510(k)

BI-RA SLIDE TEST

K-Number: K811375 · 1981-06-12

ApplicantBiologics Intl., Inc.
Decision Date1981-06-12
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BI-RA SLIDE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Biologics Intl., Inc.. It received FDA 510(k) clearance on 1981-06-12 under 510(k) number K811375. 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 BI-RA SLIDE TEST?

BI-RA SLIDE TEST is a medical device that received FDA 510(k) clearance on 1981-06-12. The listed applicant is Biologics Intl., Inc.. The 510(k) number is K811375.

When did BI-RA SLIDE TEST receive FDA 510(k) clearance?

BI-RA SLIDE TEST received FDA 510(k) clearance on 1981-06-12, under 510(k) number K811375.

Who is the listed applicant for BI-RA SLIDE TEST?

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

What is the FDA product code for BI-RA SLIDE TEST?

The FDA product code for BI-RA SLIDE TEST is DHR.

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Other records listing Biologics Intl., 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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