FDA 510(k)

PHASE II CORTISOL KIT

K-Number: K834219 · 1984-02-04

ApplicantMedical & Scientific Designs, Inc.

Decision Date1984-02-04

Product CodeCGR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PHASE II CORTISOL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medical & Scientific Designs, Inc.. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K834219. 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 PHASE II CORTISOL KIT?

PHASE II CORTISOL KIT is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Medical & Scientific Designs, Inc.. The 510(k) number is K834219.

When did PHASE II CORTISOL KIT receive FDA 510(k) clearance?

PHASE II CORTISOL KIT received FDA 510(k) clearance on 1984-02-04, under 510(k) number K834219.

Who is the listed applicant for PHASE II CORTISOL KIT?

The FDA 510(k) record lists Medical & Scientific Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHASE II CORTISOL KIT?

The FDA product code for PHASE II CORTISOL KIT is CGR.

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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.