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FDA 510(k)

NORDICLAB TESTOSTERONE RIA TEST

K-Number: K800921 · 1980-05-14

ApplicantNordiclab Intl.
Decision Date1980-05-14
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NORDICLAB TESTOSTERONE RIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Nordiclab Intl.. It received FDA 510(k) clearance on 1980-05-14 under 510(k) number K800921. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORDICLAB TESTOSTERONE RIA TEST?

NORDICLAB TESTOSTERONE RIA TEST is a medical device that received FDA 510(k) clearance on 1980-05-14. The listed applicant is Nordiclab Intl.. The 510(k) number is K800921.

When did NORDICLAB TESTOSTERONE RIA TEST receive FDA 510(k) clearance?

NORDICLAB TESTOSTERONE RIA TEST received FDA 510(k) clearance on 1980-05-14, under 510(k) number K800921.

Who is the listed applicant for NORDICLAB TESTOSTERONE RIA TEST?

The FDA 510(k) record lists Nordiclab Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORDICLAB TESTOSTERONE RIA TEST?

The FDA product code for NORDICLAB TESTOSTERONE RIA TEST is CDZ.

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Other records listing Nordiclab Intl. 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.

K801988NORDICLAB PROSTATIC ACID PHOSPHATASE RIAK801989NORDICLAB FERRITIN IRMA TESTK800920NORDICLAB ESTRADIOL RIA TESTK800922NORDICLAB PROGESTERONE RIA TESTK792189NORDICLAB TOTAL ESTRIOL RIA TESTK782157IRMA TEST, NORDICLAB FERRITIN

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Related Devices (Code: CDZ)

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.

K252728IDS-iSYS Total TestosteroneImmunodiagnostic Systems LimitedK240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems LimitedK233480Access SHBGBeckman Coulter, Inc.K223405Access TestosteroneBeckman Coulter, Inc.K211685Elecsys Testosterone IIRoche DiagnosticsK201908LIAISON Testosterone xtDiaSorin, Inc.

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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