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FDA 510(k)

ACCESS CORTISOL REAGENTS

K-Number: K940221 · 1994-04-26

ApplicantBio-Rad Laboratories, Inc.
Decision Date1994-04-26
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS CORTISOL REAGENTS 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 1994-04-26 under 510(k) number K940221. 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 ACCESS CORTISOL REAGENTS?

ACCESS CORTISOL REAGENTS is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K940221.

When did ACCESS CORTISOL REAGENTS receive FDA 510(k) clearance?

ACCESS CORTISOL REAGENTS received FDA 510(k) clearance on 1994-04-26, under 510(k) number K940221.

Who is the listed applicant for ACCESS CORTISOL REAGENTS?

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 CORTISOL REAGENTS?

The FDA product code for ACCESS CORTISOL REAGENTS is CGR.

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Related Devices (Code: 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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