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FDA 510(k)

CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK

K-Number: K830563 · 1983-05-13

ApplicantSorin Biomedica, Fiat, USA, Inc.
Decision Date1983-05-13
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1983-05-13 under 510(k) number K830563. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK?

CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK is a medical device that received FDA 510(k) clearance on 1983-05-13. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K830563.

When did CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK receive FDA 510(k) clearance?

CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK received FDA 510(k) clearance on 1983-05-13, under 510(k) number K830563.

Who is the listed applicant for CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK?

The FDA 510(k) record lists Sorin Biomedica, Fiat, USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK?

The FDA product code for CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK is CGR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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