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FDA 510(k)

RIANEN PROLACTIN 125I KIT

K-Number: K831345 · 1983-06-08

ApplicantNew England Nuclear
Decision Date1983-06-08
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIANEN PROLACTIN 125I KIT is the device name listed in this FDA 510(k) record. The listed applicant is New England Nuclear. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831345. 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 RIANEN PROLACTIN 125I KIT?

RIANEN PROLACTIN 125I KIT is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is New England Nuclear. The 510(k) number is K831345.

When did RIANEN PROLACTIN 125I KIT receive FDA 510(k) clearance?

RIANEN PROLACTIN 125I KIT received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831345.

Who is the listed applicant for RIANEN PROLACTIN 125I KIT?

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

What is the FDA product code for RIANEN PROLACTIN 125I KIT?

The FDA product code for RIANEN PROLACTIN 125I KIT is CFT.

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Other records listing New England Nuclear 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.

K841478RIANEN CYCLIC-AMP RADIOIMMUNOASSAYK840301RIANEN ESTRIOL RADIOIMMUNOASSAY KITK834038RIANEN FOLLICLE STIMULATING HORMONEK833376RIANEN LUTEINIZING HORMONE RIA KITK801245ATOMLIGHT (LIQUID SCINTILLATION SOLUTIONK792175RIANEN, VITAMIN B12 ASSAY SYSTEM

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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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