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FDA 510(k)

SERO/TEX LE TEST

K-Number: K821385 · 1982-05-28

ApplicantTexas Immunology, Inc.
Decision Date1982-05-28
Product CodeDHC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERO/TEX LE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Texas Immunology, Inc.. It received FDA 510(k) clearance on 1982-05-28 under 510(k) number K821385. The device is classified under product code DHC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERO/TEX LE TEST?

SERO/TEX LE TEST is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is Texas Immunology, Inc.. The 510(k) number is K821385.

When did SERO/TEX LE TEST receive FDA 510(k) clearance?

SERO/TEX LE TEST received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821385.

Who is the listed applicant for SERO/TEX LE TEST?

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

What is the FDA product code for SERO/TEX LE TEST?

The FDA product code for SERO/TEX LE TEST is DHC.

Other records listing Texas Immunology, Inc. as applicant

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Related Devices (Code: DHC)

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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