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FDA 510(k)

ACCESS TOTAL T3 ASSAY (MODIFICATION)

K-Number: K955435 · 1996-01-24

ApplicantBio-Rad Laboratories, Inc.
Decision Date1996-01-24
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS TOTAL T3 ASSAY (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 1996-01-24 under 510(k) number K955435. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS TOTAL T3 ASSAY (MODIFICATION)?

ACCESS TOTAL T3 ASSAY (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-01-24. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K955435.

When did ACCESS TOTAL T3 ASSAY (MODIFICATION) receive FDA 510(k) clearance?

ACCESS TOTAL T3 ASSAY (MODIFICATION) received FDA 510(k) clearance on 1996-01-24, under 510(k) number K955435.

Who is the listed applicant for ACCESS TOTAL T3 ASSAY (MODIFICATION)?

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

What is the FDA product code for ACCESS TOTAL T3 ASSAY (MODIFICATION)?

The FDA product code for ACCESS TOTAL T3 ASSAY (MODIFICATION) is CDP.

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Related Devices (Code: CDP)

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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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