FDA 510(k)

FTA-ABS TEST

K-Number: K801959 · 1980-10-23

ApplicantImmuno-Diagnostic Products, Inc.

Decision Date1980-10-23

Product CodeJWL

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

FTA-ABS TEST is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Diagnostic Products, Inc.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K801959. The device is classified under product code JWL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FTA-ABS TEST?

FTA-ABS TEST is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Immuno-Diagnostic Products, Inc.. The 510(k) number is K801959.

When did FTA-ABS TEST receive FDA 510(k) clearance?

FTA-ABS TEST received FDA 510(k) clearance on 1980-10-23, under 510(k) number K801959.

Who is the listed applicant for FTA-ABS TEST?

The FDA 510(k) record lists Immuno-Diagnostic Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FTA-ABS TEST?

The FDA product code for FTA-ABS TEST is JWL.

Other records listing Immuno-Diagnostic Products, 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: JWL)

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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.