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FDA 510(k)

PROLACTIN IRMA

K-Number: K842478 · 1984-09-14

ApplicantEuro-Diagnostics BV
Decision Date1984-09-14
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROLACTIN IRMA is the device name listed in this FDA 510(k) record. The listed applicant is Euro-Diagnostics BV. It received FDA 510(k) clearance on 1984-09-14 under 510(k) number K842478. The device is classified under product code CFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROLACTIN IRMA?

PROLACTIN IRMA is a medical device that received FDA 510(k) clearance on 1984-09-14. The listed applicant is Euro-Diagnostics BV. The 510(k) number is K842478.

When did PROLACTIN IRMA receive FDA 510(k) clearance?

PROLACTIN IRMA received FDA 510(k) clearance on 1984-09-14, under 510(k) number K842478.

Who is the listed applicant for PROLACTIN IRMA?

The FDA 510(k) record lists Euro-Diagnostics BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROLACTIN IRMA?

The FDA product code for PROLACTIN IRMA is CFT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Euro-Diagnostics BV 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.

K851332BLHI LUTEINIZING HORMONEK851148TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONEK850053BACI 6 -ADRENOCORTICOTROOP HORMONEK843930IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I

Related Devices (Code: CFT)

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.

K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISAMonobindK970281VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSJohnson & Johnson Clinical Diagnostics, Inc.K970188SEALITE SCIENCES, INC. AQUALITE PROLACTINSealite Sciences, Inc.K964748ELECSYS PROLACTIN ASSAYBoehringer Mannheim Corp.K960561DSL ACTIVE PROLACTIN ELISA MODEL 10-4500Diagnostic Systems Laboratories, Inc.K960060DSL ACTIVE PROLACTIN IRMADiagnostic Systems Laboratories, 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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