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FDA 510(k)

RADIOIMMUNOASSAY TEST SYSTEM PRL

K-Number: K830412 · 1983-04-05

ApplicantMonobind
Decision Date1983-04-05
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIOIMMUNOASSAY TEST SYSTEM PRL is the device name listed in this FDA 510(k) record. The listed applicant is Monobind. It received FDA 510(k) clearance on 1983-04-05 under 510(k) number K830412. 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 RADIOIMMUNOASSAY TEST SYSTEM PRL?

RADIOIMMUNOASSAY TEST SYSTEM PRL is a medical device that received FDA 510(k) clearance on 1983-04-05. The listed applicant is Monobind. The 510(k) number is K830412.

When did RADIOIMMUNOASSAY TEST SYSTEM PRL receive FDA 510(k) clearance?

RADIOIMMUNOASSAY TEST SYSTEM PRL received FDA 510(k) clearance on 1983-04-05, under 510(k) number K830412.

Who is the listed applicant for RADIOIMMUNOASSAY TEST SYSTEM PRL?

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

What is the FDA product code for RADIOIMMUNOASSAY TEST SYSTEM PRL?

The FDA product code for RADIOIMMUNOASSAY TEST SYSTEM PRL is CFT.

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Other records listing Monobind 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.

K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300K980088T-UPTAKE MICROPLATE EIAK972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAK971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA

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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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