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FDA 510(k)

SERO/TEX RED CELL RF TEST

K-Number: K831597 · 1983-06-30

ApplicantTexas Immunology, Inc.
Decision Date1983-06-30
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERO/TEX RED CELL RF 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 1983-06-30 under 510(k) number K831597. 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 SERO/TEX RED CELL RF TEST?

SERO/TEX RED CELL RF TEST is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Texas Immunology, Inc.. The 510(k) number is K831597.

When did SERO/TEX RED CELL RF TEST receive FDA 510(k) clearance?

SERO/TEX RED CELL RF TEST received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831597.

Who is the listed applicant for SERO/TEX RED CELL RF 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 RED CELL RF TEST?

The FDA product code for SERO/TEX RED CELL RF TEST is DHR.

Other records listing Texas Immunology, 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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