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FDA 510(k)

ST AIA-PACK TESTOSTERONE ASSAY

K-Number: K023091 · 2002-12-17

ApplicantTosoh Medics, Inc.
Decision Date2002-12-17
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ST AIA-PACK TESTOSTERONE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Medics, Inc.. It received FDA 510(k) clearance on 2002-12-17 under 510(k) number K023091. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST AIA-PACK TESTOSTERONE ASSAY?

ST AIA-PACK TESTOSTERONE ASSAY is a medical device that received FDA 510(k) clearance on 2002-12-17. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K023091.

When did ST AIA-PACK TESTOSTERONE ASSAY receive FDA 510(k) clearance?

ST AIA-PACK TESTOSTERONE ASSAY received FDA 510(k) clearance on 2002-12-17, under 510(k) number K023091.

Who is the listed applicant for ST AIA-PACK TESTOSTERONE ASSAY?

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

What is the FDA product code for ST AIA-PACK TESTOSTERONE ASSAY?

The FDA product code for ST AIA-PACK TESTOSTERONE ASSAY is CDZ.

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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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