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FDA 510(k)

AIA-PACK CORT ASSAY

K-Number: K954591 · 1995-12-15

ApplicantTosoh Medics, Inc.
Decision Date1995-12-15
Product CodeJFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIA-PACK CORT 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 1995-12-15 under 510(k) number K954591. The device is classified under product code JFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIA-PACK CORT ASSAY?

AIA-PACK CORT ASSAY is a medical device that received FDA 510(k) clearance on 1995-12-15. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K954591.

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

AIA-PACK CORT ASSAY received FDA 510(k) clearance on 1995-12-15, under 510(k) number K954591.

Who is the listed applicant for AIA-PACK CORT 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 AIA-PACK CORT ASSAY?

The FDA product code for AIA-PACK CORT ASSAY is JFT.

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Related Devices (Code: JFT)

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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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