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FDA 510(k)

N-TERMINAL HPTH BY RIA

K-Number: K811418 · 1981-06-24

ApplicantImmuno Nuclear Corp.
Decision Date1981-06-24
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

N-TERMINAL HPTH BY RIA is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Nuclear Corp.. It received FDA 510(k) clearance on 1981-06-24 under 510(k) number K811418. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N-TERMINAL HPTH BY RIA?

N-TERMINAL HPTH BY RIA is a medical device that received FDA 510(k) clearance on 1981-06-24. The listed applicant is Immuno Nuclear Corp.. The 510(k) number is K811418.

When did N-TERMINAL HPTH BY RIA receive FDA 510(k) clearance?

N-TERMINAL HPTH BY RIA received FDA 510(k) clearance on 1981-06-24, under 510(k) number K811418.

Who is the listed applicant for N-TERMINAL HPTH BY RIA?

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

What is the FDA product code for N-TERMINAL HPTH BY RIA?

The FDA product code for N-TERMINAL HPTH BY RIA is CEW.

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Related Devices (Code: CEW)

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.

K231927Elecsys PTH , Elecsys PTH STATRoche DiagnosticsK232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.

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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