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FDA 510(k)

SERUM 11-DESOXYCORTISOL I AS TRACER

K-Number: K791740 · 1979-09-27

ApplicantRadioassay Systems Laboratories, Inc.
Decision Date1979-09-27
Product CodeJKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM 11-DESOXYCORTISOL I AS TRACER is the device name listed in this FDA 510(k) record. The listed applicant is Radioassay Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1979-09-27 under 510(k) number K791740. The device is classified under product code JKB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERUM 11-DESOXYCORTISOL I AS TRACER?

SERUM 11-DESOXYCORTISOL I AS TRACER is a medical device that received FDA 510(k) clearance on 1979-09-27. The listed applicant is Radioassay Systems Laboratories, Inc.. The 510(k) number is K791740.

When did SERUM 11-DESOXYCORTISOL I AS TRACER receive FDA 510(k) clearance?

SERUM 11-DESOXYCORTISOL I AS TRACER received FDA 510(k) clearance on 1979-09-27, under 510(k) number K791740.

Who is the listed applicant for SERUM 11-DESOXYCORTISOL I AS TRACER?

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

What is the FDA product code for SERUM 11-DESOXYCORTISOL I AS TRACER?

The FDA product code for SERUM 11-DESOXYCORTISOL I AS TRACER is JKB.

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Other records listing Radioassay Systems Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K862204RSL (125I) ALDOSTERONE KITK842960ANDROSTENEDIONE BY RIAK840886HYDROXYPROGESTERONE BY RIA 17AK831855HATCH KITK802195DEHYDROEPIANDROSTERONE SULFATE KIT RIAK800126RSL (125 L) PROGESTERONE KIT

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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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