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FDA 510(k)

N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)

K-Number: K874299 · 1987-11-23

ApplicantIncstar Corp.
Decision Date1987-11-23
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA) is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1987-11-23 under 510(k) number K874299. 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-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)?

N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA) is a medical device that received FDA 510(k) clearance on 1987-11-23. The listed applicant is Incstar Corp.. The 510(k) number is K874299.

When did N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA) receive FDA 510(k) clearance?

N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA) received FDA 510(k) clearance on 1987-11-23, under 510(k) number K874299.

Who is the listed applicant for N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)?

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

What is the FDA product code for N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)?

The FDA product code for N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA) 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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