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FDA 510(k)

NORDICLAB PROGESTERONE RIA TEST

K-Number: K800922 · 1980-05-14

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

Device Summary

NORDICLAB PROGESTERONE 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 K800922. The device is classified under product code JLS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORDICLAB PROGESTERONE RIA TEST?

NORDICLAB PROGESTERONE 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 K800922.

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

NORDICLAB PROGESTERONE RIA TEST received FDA 510(k) clearance on 1980-05-14, under 510(k) number K800922.

Who is the listed applicant for NORDICLAB PROGESTERONE 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 PROGESTERONE RIA TEST?

The FDA product code for NORDICLAB PROGESTERONE RIA TEST is JLS.

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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 TESTK800921NORDICLAB TESTOSTERONE RIA TESTK792189NORDICLAB TOTAL ESTRIOL RIA TESTK782157IRMA TEST, NORDICLAB FERRITIN

View all 8 devices →

Related Devices (Code: JLS)

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.

K040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAIbl GmbHK973898PROGESTERONE ELISAKmi Diagnostics, Inc.K972133VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)Johnson & Johnson Clinical Diagnostics, Inc.K971725OPUS PROGESTERONEBehring Diagnostics, Inc.K964841ELECSYS PROGESTERONE ASSAYBoehringer Mannheim Corp.K965084VIDAS PROESTERONE (PRG) (30 409)bioMerieux, 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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