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FDA 510(k)

THE THERATEST ACA TEST

K-Number: K905301 · 1991-01-14

ApplicantTheratest Laboratories, Inc.
Decision Date1991-01-14
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THE THERATEST ACA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Theratest Laboratories, Inc.. It received FDA 510(k) clearance on 1991-01-14 under 510(k) number K905301. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE THERATEST ACA TEST?

THE THERATEST ACA TEST is a medical device that received FDA 510(k) clearance on 1991-01-14. The listed applicant is Theratest Laboratories, Inc.. The 510(k) number is K905301.

When did THE THERATEST ACA TEST receive FDA 510(k) clearance?

THE THERATEST ACA TEST received FDA 510(k) clearance on 1991-01-14, under 510(k) number K905301.

Who is the listed applicant for THE THERATEST ACA TEST?

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

What is the FDA product code for THE THERATEST ACA TEST?

The FDA product code for THE THERATEST ACA TEST is GFO.

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Other records listing Theratest Laboratories, 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.

K090753THERATEST EL-ANTI-CCP/2K090760THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120K071692THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMSK061376EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3K060176EL-ACL SCREEN; EL-ACL IGM, IGG, IGAK051066THERATEST EL-ANA PROFILES

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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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